Non-biased deflectable electrode to minimize contact between ultrasonic blade and electrode

ABSTRACT

An end-effector and a surgical instrument including the end-effector are disclosed. The end-effector includes a clamp arm and an ultrasonic blade configured to acoustically couple to an ultrasonic transducer and to electrically couple to a pole of an electrical generator. The clamp arm incudes a clamp jaw, a cantilever electrode, and a clamp arm. The cantilever electrode is biased in a direction toward the clamp jaw and the clamp arm includes a retainer to oppose a biasing force and maintain the cantilever electrode in a substantially flat configuration relative to the ultrasonic blade. A skirt may be disposed around the clamp jaw. The clamp arm pad may include multiple support elements arranged in multiple rows to support the cantilever electrode.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application Ser. No. 62/955,292, titled COMBINATIONENERGY MODALITY END-EFFECTOR, filed Dec. 30, 2019, the disclosure ofwhich is herein incorporated by reference in its entirety.

TECHNICAL FIELD

The present disclosure generally relates to end-effectors adapted andconfigured to operate with multiple energy modalities to enable tissuesealing and cutting employing simultaneously, independently, orsequentially applied energy modalities. More particularly, the presentdisclosure relates to end-effectors adapted and configured to operatewith surgical instruments that employ combined ultrasonic andelectrosurgical systems, such as monopolar or bipolar radio frequency(RF), to enable tissue sealing and cutting employing simultaneously,independently, or sequentially applied ultrasonic and electrosurgicalenergy modalities. The energy modalities may be applied based on tissueparameters or other algorithms. The end-effectors may be adapted andconfigured to couple to hand held or robotic surgical systems.

BACKGROUND

Ultrasonic surgical instruments employing ultrasonic energy modalitiesare finding increasingly widespread applications in surgical proceduresby virtue of the unique performance characteristics of such instruments.Depending upon specific instrument configurations and operationalparameters, ultrasonic surgical instruments can provide substantiallysimultaneous cutting of tissue and hemostasis by coagulation, desirablyminimizing patient trauma. The cutting action is typically realized byan end-effector, ultrasonic blade, or ultrasonic blade tip, at thedistal end of the instrument, which transmits ultrasonic energy totissue brought into contact with the end-effector. An ultrasonicend-effector may comprise an ultrasonic blade, a clamp arm, and a pad,among other components.

Some surgical instruments utilize ultrasonic energy for both precisecutting and controlled coagulation. Ultrasonic energy cuts andcoagulates by vibrating a blade in contact with tissue. Vibrating athigh frequencies (e.g., 55,500 times per second), the ultrasonic bladedenatures protein in the tissue to form a sticky coagulum. Pressureexerted on tissue with the blade surface collapses blood vessels andallows the coagulum to form a hemostatic seal. The precision of cuttingand coagulation is controlled by the surgeon's technique and adjustingthe power level, blade edge, tissue traction, and blade pressure.

Electrosurgical instruments for applying electrical energy modalities totissue to treat, seal, cut, and/or destroy tissue also are findingincreasingly widespread applications in surgical procedures. Anelectrosurgical instrument typically includes an instrument having adistally-mounted end-effector comprising one or more than one electrode.The end-effector can be positioned against the tissue such thatelectrical current is introduced into the tissue. Electrosurgicalinstruments can be configured for bipolar or monopolar operation. Duringbipolar operation, current is introduced though a first electrode (e.g.,active electrode) into the tissue and returned from the tissue through asecond electrode (e.g., return electrode). During monopolar operation,current is introduced into the tissue by an active electrode of theend-effector and returned through a return electrode such as a groundingpad, for example, separately coupled to the body of a patient. Heatgenerated by the current flowing through the tissue may form hemostaticseals within the tissue and/or between tissues and thus may beparticularly useful for sealing blood vessels, for example. Theend-effector of an electrosurgical instrument also may include a cuttingmember that is movable relative to the tissue and the electrodes totransect the tissue. Electrosurgical end-effectors may be adapted andconfigured to couple to hand held instruments as well as roboticinstruments.

Electrical energy applied by an electrosurgical instrument can betransmitted to the instrument by a generator in communication with thehand piece. The electrical energy may be in the form of radio frequency(“RF”) energy. RF energy is a form of electrical energy that may be inthe frequency range of 200 kilohertz (kHz) to 1 megahertz (MHz). Inapplication, an electrosurgical instrument can transmit low frequency RFenergy through tissue, which causes ionic agitation, or friction, ineffect resistive heating, thereby increasing the temperature of thetissue. Because a sharp boundary is created between the affected tissueand the surrounding tissue, surgeons can operate with a high level ofprecision and control, without sacrificing un-targeted adjacent tissue.The low operating temperatures of RF energy is useful for removing,shrinking, or sculpting soft tissue while simultaneously sealing bloodvessels. RF energy works particularly well on connective tissue, whichis primarily comprised of collagen and shrinks when contacted by heat.

The RF energy may be in a frequency range described in EN60601-2-2:2009+A11:2011, Definition 201.3.218—HIGH FREQUENCY. Forexample, the frequency in monopolar RF applications may be typicallyrestricted to less than 5 MHz. However, in bipolar RF energyapplications, the frequency can be almost anything. Frequencies above200 kHz can be typically used for monopolar applications in order toavoid the unwanted stimulation of nerves and muscles that would resultfrom the use of low frequency current. Lower frequencies may be used forbipolar applications if the risk analysis shows the possibility ofneuromuscular stimulation has been mitigated to an acceptable level.Normally, frequencies above 5 MHz are not used in order to minimize theproblems associated with high frequency leakage currents. Higherfrequencies may, however, be used in the case of bipolar applications.It is generally recognized that 10 mA is the lower threshold of thermaleffects on tissue.

Ultrasonic surgical instruments and electrosurgical instruments of thenature described herein can be configured for open surgical procedures,minimally invasive surgical procedures, or non-invasive surgicalprocedures. Minimally invasive surgical procedures involve the use of acamera and instruments inserted through small incisions in order tovisualize and treat conditions within joints or body cavities. Minimallyinvasive procedures may be performed entirely within the body or, insome circumstances, can be used together with a smaller open approach.These combined approaches, known as “arthroscopic, laparoscopic orthoracoscopic-assisted surgery,” for example. The surgical instrumentsdescribed herein also can be used in non-invasive procedures such asendoscopic surgical procedures, for example. The instruments may becontrolled by a surgeon using a hand held instrument or a robot.

A challenge of utilizing these surgical instruments is the inability tocontrol and customize single or multiple energy modalities depending onthe type of tissue being treated. It would be desirable to provideend-effectors that overcome some of the deficiencies of current surgicalinstruments and improve the quality of tissue treatment, sealing, orcutting or combinations thereof. The combination energy modalityend-effectors described herein overcome those deficiencies and improvethe quality of tissue treatment, sealing, or cutting or combinationsthereof.

SUMMARY

In one aspect, an apparatus is provided for dissecting and coagulatingtissue. The apparatus comprises a surgical instrument comprising anend-effector adapted and configured to deliver a plurality of energymodalities to tissue at a distal end thereof. The energy modalities maybe applied simultaneously, independently, or sequentially. A generatoris electrically coupled to the surgical instrument and is configured tosupply a plurality of energy modalities to the end-effector. In oneaspect, the generator is configured to supply electrosurgical energy(e.g., monopolar or bipolar radio frequency (RF) energy) and ultrasonicenergy to the end-effector to allow the end-effector to interact withthe tissue. The energy modalities may be supplied to the end-effector bya single generator or multiple generators.

In various aspects, the present disclosure provides a surgicalinstrument configured to deliver at least two energy types (e.g.,ultrasonic, monopolar RF, bipolar RF, microwave, or irreversibleelectroporation [IRE]) to tissue. The surgical instrument includes afirst activation button for activating energy, a second button forselecting an energy mode for the activation button. The second button isconnected to a circuit that uses at least one input parameter to definethe energy mode. The input parameter can be modified remotely throughconnection to a generator or through a software update.

In one aspect, the present disclosure provides a combinationultrasonic/bipolar RF energy surgical device. The combinationultrasonic/bipolar RF energy surgical device comprises an end-effector.The end-effector comprises a clamp arm and an ultrasonic blade. Theclamp arm comprises a movable clamp jaw, a compliant polymeric pad, andat least one bipolar RF electrode. The at least one electrode is coupledto a positive pole of an RF generator and the ultrasonic blade iscoupled to the negative pole of the RF generator. The ultrasonic bladeis acoustically coupled to an ultrasonic transducer stack that is drivenby an ultrasonic generator. In one aspect, the at least one electrodeacts a deflectable support with respect to an opposing ultrasonic blade.The at least one electrode crosses over the ultrasonic blade and isconfigured to be deflectable with respect to the clamp arm havingfeatures to change the mechanical properties of the tissue compressionunder the at least one electrode. The at least one electrode includes afeature to prevent inadvertent contact between the electrode and theultrasonic blade.

In another aspect, the present disclosure provides a combinationultrasonic/bipolar RF energy surgical device. The combinationultrasonic/bipolar RF energy surgical device comprises an end-effector.The end-effector comprises a clamp arm and an ultrasonic blade. Theclamp arm comprises a movable clamp jaw, a compliant polymeric pad, andat least one bipolar RF electrode. The at least one electrode is coupledto a positive pole of an RF generator and the ultrasonic blade iscoupled to the negative pole of the RF generator. The ultrasonic bladeis acoustically coupled to an ultrasonic transducer stack that is drivenby an ultrasonic generator. In one aspect, the movable clamp jawcomprises at least one non-biased deflectable electrode to minimizecontact between the ultrasonic blade and the RF electrode. Theultrasonic blade pad contains a feature for securing the electrode tothe pad. As the pad height wears or is cut through, the height of theelectrode with respect to the clamp jaw is progressively adjusted. Oncethe clamp jaw is moved away from the ultrasonic blade, the electroderemains in its new position.

In another aspect, the present disclosure provides a combinationultrasonic/bipolar RF energy surgical device. The combinationultrasonic/bipolar RF energy surgical device comprises an end-effector.The end-effector comprises a clamp arm and an ultrasonic blade. Theclamp arm comprises a movable clamp jaw, a compliant polymeric pad, andat least one bipolar RF electrode. The at least one electrode is coupledto a positive pole of an RF generator and the ultrasonic blade iscoupled to the negative pole of the RF generator. The ultrasonic bladeis acoustically coupled to an ultrasonic transducer stack that is drivenby an ultrasonic generator. In one aspect, the at least one bipolar RFelectrode is deflectable and has a higher distal bias than proximalbias. The bipolar RF electrode is deflectable with respect to the clampjaw. The end-effector is configured to change the mechanical propertiesof the tissue compression proximal to distal end to create a moreuniform or differing pattern of pressure than due to the clamping alone.

In another aspect, the present disclosure provides a combinationultrasonic/bipolar RF energy surgical device. The combinationultrasonic/bipolar RF energy surgical device comprises an end-effector.The end-effector comprises a clamp arm and an ultrasonic blade. Theclamp arm comprises a movable clamp jaw, a compliant polymeric pad, andat least one bipolar RF electrode. The at least one electrode is coupledto a positive pole of an RF generator and the ultrasonic blade iscoupled to the negative pole of the RF generator. The ultrasonic bladeis acoustically coupled to an ultrasonic transducer stack that is drivenby an ultrasonic generator. In one aspect, the bipolar RF electrode isdeflectable and the end-effector provides variable compression/biasalong the length of the deflectable electrode. The end-effector isconfigured to change the mechanical properties of the tissue compressionunder the electrodes based on clamp jaw closure or clamping amount.

In another aspect, the present disclosure provides a combinationultrasonic/bipolar RF energy surgical device. The combinationultrasonic/bipolar RF energy surgical device comprises an end-effector.The end-effector comprises a clamp arm and an ultrasonic blade. Theclamp arm comprises a movable clamp jaw, a compliant polymeric pad, andat least one bipolar RF electrode. The at least one electrode is coupledto a positive pole of an RF generator and the ultrasonic blade iscoupled to the negative pole of the RF generator. The ultrasonic bladeis acoustically coupled to an ultrasonic transducer stack that is drivenby an ultrasonic generator. The one aspect, the pad includes asymmetricsegments to provide support for the ultrasonic blade support and theelectrode is movable. The asymmetric segmented pad is configured forcooperative engagement with the movable bipolar RF electrode. Thesegmented ultrasonic support pad extends at least partially through thebipolar RF electrode. At least one pad element is significantly tallerthan a second pad element. The first pad element extends entirelythrough the bipolar RF electrode and the second pad element extendspartially through the bipolar RF electrode. The first pad element andthe second pad element are made of dissimilar materials.

In another aspect, the present disclosure provides a combinationultrasonic/bipolar RF energy surgical device. The combinationultrasonic/bipolar RF energy surgical device comprises an end-effector.The end-effector comprises a clamp arm and an ultrasonic blade. Theclamp arm comprises a movable clamp jaw, a compliant polymeric pad, andat least one bipolar RF electrode. The at least one electrode is coupledto a positive pole of an RF generator and the ultrasonic blade iscoupled to the negative pole of the RF generator. The ultrasonic bladeis acoustically coupled to an ultrasonic transducer stack that is drivenby an ultrasonic generator. In one aspect, variations in the physicalparameters of the electrode in combination with a deflectable electrodeare employed to change the energy density delivered to the tissue andthe tissue interactions. The physical aspects of the electrode varyalong its length in order to change the contact area and/or the energydensity of the electrode to tissue as the electrode also deflects.

In another aspect, the present disclosure provides a combinationultrasonic/bipolar RF energy surgical device. The combinationultrasonic/bipolar RF energy surgical device comprises an end-effector.The end-effector comprises a clamp arm and an ultrasonic blade. Theclamp arm comprises a movable clamp jaw, a compliant polymeric pad, andat least one bipolar RF electrode. The at least one electrode is coupledto a positive pole of an RF generator and the ultrasonic blade iscoupled to the negative pole of the RF generator. The ultrasonic bladeis acoustically coupled to an ultrasonic transducer stack that is drivenby an ultrasonic generator. In one aspect, an ultrasonic transducercontrol algorithm is provided to reduce the power delivered by theultrasonic or RF generator when a short circuit of contact between theultrasonic blade and the electrode is detected to prevent damage to theultrasonic blade. The ultrasonic blade control algorithm monitors forelectrical shorting or ultrasonic blade to electrode contact. Thisdetection is used to adjust the power/amplitude level of the ultrasonictransducer when the electrical threshold minimum is exceeded and adjuststhe transducer power/amplitude threshold to a level below the minimumthreshold that would cause damage to the ultrasonic blade, ultrasonicgenerator, bipolar RF electrode, or bipolar RF generator. The monitoredelectrical parameter could be tissue impedance (Z) or electricalcontinuity. The power adjustment could be to shut off the ultrasonicgenerator, bipolar RF generator, of the surgical device or it could be aproportionate response to either the electrical parameter, pressure, ortime or any combination of these parameters.

In another aspect, the present disclosure provides a combinationultrasonic/bipolar RF energy surgical device. The combinationultrasonic/bipolar RF energy surgical device comprises an end-effector.The end-effector comprises a clamp arm and an ultrasonic blade. Theclamp arm comprises a movable clamp jaw, a compliant polymeric pad, andat least one bipolar RF electrode. The at least one electrode is coupledto a positive pole of an RF generator and the ultrasonic blade iscoupled to the negative pole of the RF generator. The ultrasonic bladeis acoustically coupled to an ultrasonic transducer stack that is drivenby an ultrasonic generator. In one aspect, the clamp jaw features oraspects are provided in the clamp ram to minimize tissue sticking andimprove tissue control. The clamp arm tissue path or clamp area includesfeatures configured to adjust the tissue path relative to the clamparm/ultrasonic blade to create a predefined location of contact toreduce tissue sticking and charring.

In another aspect, the present disclosure provides a combinationultrasonic/bipolar RF energy surgical device. The combinationultrasonic/bipolar RF energy surgical device comprises an end-effector.The end-effector comprises a clamp arm and an ultrasonic blade. Theclamp arm comprises a movable clamp jaw, a compliant polymeric pad, andat least one bipolar RF electrode. The at least one electrode is coupledto a positive pole of an RF generator and the ultrasonic blade iscoupled to the negative pole of the RF generator. The ultrasonic bladeis acoustically coupled to an ultrasonic transducer stack that is drivenby an ultrasonic generator. In one aspect, a partially conductive clamparm pad is provided to enable electrode wear through and minimizeelectrical shorting between the ultrasonic blade and the bipolar RFelectrode. The clamp arm pad includes electrically conductive andnon-conductive portions allowing it to act as one of the bipolar RFelectrodes while also acting as the wearable support structure for theultrasonic blade. The electrically conductive portions of the clamp rampad are positioned around the perimeter of the pad and not positioneddirectly below the ultrasonic blade contact area. The electricallyconductive portion is configured to degrade or wear to prevent anycontact with the ultrasonic blade from interrupting the electricalconductivity of the remaining electrically conductive pad.

In addition to the foregoing, various other method and/or system and/orprogram product aspects are set forth and described in the teachingssuch as text (e.g., claims and/or detailed description) and/or drawingsof the present disclosure.

The foregoing is a summary and thus may contain simplifications,generalizations, inclusions, and/or omissions of detail; consequently,those skilled in the art will appreciate that the summary isillustrative only and is NOT intended to be in any way limiting. Otheraspects, features, and advantages of the devices and/or processes and/orother subject matter described herein will become apparent in theteachings set forth herein.

In one or more various aspects, related systems include but are notlimited to circuitry and/or programming for effecting herein-referencedmethod aspects; the circuitry and/or programming can be virtually anycombination of hardware, software, and/or firmware configured to affectthe herein-referenced method aspects depending upon the design choicesof the system designer. In addition to the foregoing, various othermethod and/or system aspects are set forth and described in theteachings such as text (e.g., claims and/or detailed description) and/ordrawings of the present disclosure.

Further, it is understood that any one or more of thefollowing-described forms, expressions of forms, examples, can becombined with any one or more of the other following-described forms,expressions of forms, and examples.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects, embodiments,and features described above, further aspects, embodiments, and featureswill become apparent by reference to the drawings and the followingdetailed description.

FIGURES

The novel features of the described forms are set forth withparticularity in the appended claims. The described forms, however, bothas to organization and methods of operation, may be best understood byreference to the following description, taken in conjunction with theaccompanying drawings in which:

FIG. 1 is a perspective view of a clamp arm portion of an end-effectorfor use with a combined ultrasonic/RF device, according to at least oneaspect of the present disclosure.

FIG. 2 is an exploded view of the clamp arm shown in FIG. 1, accordingto at least one aspect of the present disclosure.

FIGS. 3 and 4 are perspective views of the frame, according to at leastone aspect of the present disclosure.

FIG. 5 is a perspective view of the electrode, according to at least oneaspect of the present disclosure.

FIG. 6 is a perspective view of the clamp arm pad, according to at leastone aspect of the present disclosure.

FIG. 7 is a perspective top view of the large gap pad, according to atleast one aspect of the present disclosure.

FIG. 8 is a perspective top view of the small gap pad, according to atleast one aspect of the present disclosure.

FIG. 9 is a perspective bottom view of the small gap pad shown in FIG.8.

FIGS. 10-12 illustrate an effector comprising a shortened clamp arm fordeflectable/cantilever electrode applications, according to variousaspects of the present disclosure, where:

FIG. 10 is a side view of an end-effector comprising a shortened clamparm, an ultrasonic blade, an electrode, and a clamp arm pad, accordingto at least one aspect of the present disclosure;

FIG. 11 is a top view of the end-effector, according to at least oneaspect of the present disclosure; and

FIG. 12 illustrates a clamp arm comprising a clamp jaw, an electrode,and a clamp arm pad, according to at least one aspect of the presentdisclosure.

FIG. 13 illustrates an end-effector clamp arm comprising a clamp jaw, anelectrode, and a clamp arm pad, according to at least one aspect of thepresent disclosure.

FIG. 14 illustrates an end-effector clamp arm comprising a clamp jaw, anelectrode, and a clamp arm pad, according to at least one aspect of thepresent disclosure.

FIG. 15 illustrates an end-effector clamp arm comprising a clamp jaw, anelectrode, and a clamp arm pad, according to at least one aspect of thepresent disclosure.

FIG. 16 illustrates bottom retainer tooth that is worn away such thatthe electrode can move toward the clamp jaw due to the pre-formed curve,according to at least one aspect of the present disclosure.

FIG. 17 illustrates an end-effector clamp arm comprising a clamp jaw, anelectrode, and a clamp arm pad, according to at least one aspect of thepresent disclosure.

FIG. 18 illustrates a retainer wall with a tapered profile worn awaysuch that there is sufficient melting/flowing away from the retainerwall with the tapered profile region to allow the electrode to movetoward the clamp jaw due to the pre-formed curve, according to at leastone aspect of the present disclosure.

FIG. 19 illustrates a clamp arm comprising a clamp jaw, an electrode,and a clamp arm pad, according to at least one aspect of the presentdisclosure.

FIG. 20 illustrates a magnified view of the distal end of the clamp armwith the clamp arm pad removed to expose the distal skirt, according toat least one aspect of the present disclosure.

FIGS. 21A-21C illustrate an end-effector comprising a clamp arm, anelectrode, a clamp arm pad, and an ultrasonic blade, where the clamp armpad comprises support elements to support the electrode, according to atleast one aspect of the present disclosure, where:

FIG. 21A shows a new clamp arm pad and an electrode supported by supportelement (tab1, tab2, tab3);

FIG. 21B shows the clamp arm pad heating up an causes the first row ofsupport elements (tab1) to melt and wear away causing the electrode todrop in height (h); and

FIG. 21C shows that as the clamp arm pad continues heating and wearing,the second row support elements (tab2) to melt and wear away causing theheight (h) of the electrode to further drop down.

FIGS. 22-24 illustrate an end-effector comprising a clamp arm, anultrasonic blade, a lattice cushion, a flexible electrode disposed abovethe lattice cushion, and a plurality of hard spacers to set a gapbetween the flexible electrode and the ultrasonic blade, according to atleast one aspect of the present disclosure, where:

FIG. 22 illustrates the clamp arm open and tissue of non-uniformthickness (T_(1a), T_(2a), T_(3a)) is disposed over the flexibleelectrode;

FIG. 23 the clamp arm is closed to compress the tissue; and

FIG. 24 is an exploded view of the end-effector shown in FIGS. 22-23.

FIG. 25 is a section view of a conductive polymer clamp arm pad,according to at least one aspect of the present disclosure.

FIG. 26 is a perspective view of a clamp arm pad configured to replace aconventional electrode, according to at least one aspect of the presentdisclosure.

FIG. 27 illustrates a clamp arm comprising the clamp arm pad describedin FIG. 26, according to at least one aspect of the present disclosure.

FIG. 28 illustrates clamp arm pads configured as described in FIGS.26-27, according to at least one aspect of the present disclosure.

FIG. 29 is a section view of a clamp arm comprising a composite clamparm pad in contact with tissue, according to at least one aspect of thepresent disclosure.

FIG. 30 illustrates a clamp arm comprising a clamp jaw to support acarrier or stamping attached to the clamp jaw and a clamp arm pad,according to at least one aspect of the present disclosure.

FIG. 31 is a section view taken at section 31-31 in FIG. 30.

FIG. 32 is a section view taken at section 32-32 in FIG. 30.

FIG. 33 is a section view of an alternative implementation of a clamparm comprising a clamp jaw, an electrically conductive pad, and anelectrically non-conductive pad, according to at least one aspect of thepresent disclosure.

FIG. 34 is a section view of an alternative implementation of a clamparm comprising a clamp jaw, a carrier or stamping welded to the clampjaw, an electrically conductive pad, and an electrically non-conductivepad, according to at least one aspect of the present disclosure.

FIG. 35 illustrates insert molded electrodes, according to at least oneaspect of the present disclosure.

FIG. 36 illustrates an end-effector comprising an ultrasonic blade, aclamp arm, and a clamp arm pad comprising an electrically conductivefilm, according to at least one aspect of the present disclosure.

FIG. 37 illustrates the clamp arm shown in FIG. 36.

FIG. 38 is a section view of the clamp arm taken along section 38-38 inFIG. 37.

FIG. 39 illustrates a clamp arm comprising a partially electricallyconductive clamp arm pad, according to at least one aspect of the resentdisclosure.

FIG. 40 illustrates a surgical device comprising a mode selection buttonswitch on the device, according to at least one aspect of the presentdisclosure.

FIGS. 41A-41C illustrate three options for selecting the variousoperating modes of the surgical device, according to at least one aspectof the present disclosure, where:

FIG. 41A shows a first mode selection option where the button switch canbe pressed forward or backward to cycle the surgical instrument throughthe various modes;

FIG. 41B shows a second mode selection option where the button switch ispressed up or down to cycle the surgical instrument through the variousmodes; and

FIG. 41C shows a third mode selection option where the button switch ispressed forward, backward, up, or down to cycle the surgical instrumentthrough the various modes.

FIG. 42 illustrates a surgical device comprising a mode selection buttonswitch on the back of the device, according to at least one aspect ofthe present disclosure.

FIG. 43A shows a first mode selection option where as the mode buttonswitch is pressed to toggled through various modes, colored lightindicates the selected mode on the user interface.

FIG. 43B shows a second mode selection option where as the mode buttonswitch is pressed to toggle through various modes a screen indicates theselected mode (e.g., LCD, e-ink).

FIG. 43C shows a third mode selection option where as the mode buttonswitch is pressed to toggle through various modes, labelled lightsindicate the selected mode.

FIG. 43D shows a fourth mode selection option where as a labeled buttonswitch is pressed to select a mode, when a labeled button switch isselected, it is illuminated to indicate mode selected.

FIG. 44 illustrates a surgical device comprising a trigger activationmechanism, according to at least one aspect of the present disclosure.

FIG. 45 illustrates an alternative clamp arm comprising a metal clampjaw, an electrode, a plurality of clamp arm pads, and gap pads,according to at least one aspect of the present disclosure.

FIG. 46 is a surgical system comprising a surgical hub paired with avisualization system, a robotic system, and an intelligent instrument,in accordance with at least one aspect of the present disclosure.

FIG. 47 illustrates an example of a generator, in accordance with atleast one aspect of the present disclosure.

FIG. 48 is a diagram of various modules and other components that arecombinable to customize modular energy systems, in accordance with atleast one aspect of the present disclosure.

FIG. 49A is a first illustrative modular energy system configurationincluding a header module and a display screen that renders a graphicaluser interface (GUI) for relaying information regarding modulesconnected to the header module, in accordance with at least one aspectof the present disclosure.

FIG. 49B is the modular energy system shown in FIG. 49A mounted to acart, in accordance with at least one aspect of the present disclosure.

FIG. 50 depicts a perspective view of an exemplary surgical systemhaving a generator and a surgical instrument operable to treat tissuewith ultrasonic energy and bipolar RF energy, in accordance with atleast one aspect of the present disclosure.

FIG. 51 depicts a top perspective view of an end effector of thesurgical instrument of FIG. 50, having a clamp arm that provides a firstelectrode and an ultrasonic blade that provides a second electrode, inaccordance with at least one aspect of the present disclosure.

FIG. 52 depicts a bottom perspective view of the end effector of FIG.51, in accordance with at least one aspect of the present disclosure.

FIG. 53 depicts a partially exploded perspective view of the surgicalinstrument of FIG. 50, in accordance with at least one aspect of thepresent disclosure.

FIG. 54 depicts an enlarged exploded perspective view of a distalportion of the shaft assembly and the end effector of the surgicalinstrument of FIG. 50, in accordance with at least one aspect of thepresent disclosure.

DESCRIPTION

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Dec. 30, 2019, the disclosure of each ofwhich is herein incorporated by reference in its respective entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/955,294,        entitled USER INTERFACE FOR SURGICAL INSTRUMENT WITH COMBINATION        ENERGY MODALITY END-EFFECTOR;    -   U.S. Provisional Patent Application Ser. No. 62/955,299,        entitled ELECTROSURGICAL INSTRUMENTS FOR COMBINATION ENERGY        DELIVERY; and    -   U.S. Provisional Patent Application Ser. No. 62/955,306,        entitled SURGICAL INSTRUMENTS.

Applicant of the present application owns the following U.S. PatentApplications that were filed on even date herewith, and which are eachherein incorporated by reference in their respective entireties:

-   -   Attorney Docket No. END9232USNP1/190715-1, entitled USER        INTERFACE FOR SURGICAL INSTRUMENT WITH COMBINATION ENERGY        MODALITY END-EFFECTOR;    -   Attorney Docket No. END9233USNP1/190716-1M, entitled METHOD OF        OPERATING A COMBINATION ULTRASONIC/BIPOLAR RF SURGICAL DEVICE        WITH A COMBINATION ENERGY MODALITY END-EFFECTOR;    -   Attorney Docket No. END9233USNP2/190716-2, entitled DEFLECTABLE        SUPPORT OF RF ENERGY ELECTRODE WITH RESPECT TO OPPOSING        ULTRASONIC BLADE;    -   Attorney Docket No. END9233USNP4/190716-4, entitled DEFLECTABLE        ELECTRODE WITH HIGHER DISTAL BIAS RELATIVE TO PROXIMAL BIAS;    -   Attorney Docket No. END9233USNP5/190716-5, entitled DEFLECTABLE        ELECTRODE WITH VARIABLE COMPRESSION BIAS ALONG THE LENGTH OF THE        DEFLECTABLE ELECTRODE;    -   Attorney Docket No. END9233USNP6/190716-6, entitled ASYMMETRIC        SEGMENTED ULTRASONIC SUPPORT PAD FOR COOPERATIVE ENGAGEMENT WITH        A MOVABLE RF ELECTRODE;    -   Attorney Docket No. END9233USNP7/190716-7, entitled VARIATION IN        ELECTRODE PARAMETERS AND DEFLECTABLE ELECTRODE TO MODIFY ENERGY        DENSITY AND TISSUE INTERACTION;    -   Attorney Docket No. END9233USNP8/190716-8, entitled TECHNIQUES        FOR DETECTING ULTRASONIC BLADE TO ELECTRODE CONTACT AND REDUCING        POWER TO ULTRASONIC BLADE;    -   Attorney Docket No. END9233USNP9/190716-9, entitled CLAMP ARM        JAW TO MINIMIZE TISSUE STICKING AND IMPROVE TISSUE CONTROL; and    -   Attorney Docket No. END9233USNP10/190716-10, entitled PARTIALLY        CONDUCTIVE CLAMP ARM PAD TO ENABLE ELECTRODE WEAR THROUGH AND        MINIMIZE SHORT CIRCUITING.

Applicant of the present application owns the following U.S. PatentApplications that were filed on May 28, 2020, and which are each hereinincorporated by reference in their respective entireties:

-   -   U.S. patent application Ser. No. 16/885,813, entitled METHOD FOR        AN ELECTROSURGICAL PROCEDURE;    -   U.S. patent application Ser. No. 16/885,820, entitled        ARTICULATABLE SURGICAL INSTRUMENT;    -   U.S. patent application Ser. No. 16/885,823, entitled SURGICAL        INSTRUMENT WITH JAW ALIGNMENT FEATURES;    -   U.S. patent application Ser. No. 16/885,826, entitled SURGICAL        INSTRUMENT WITH ROTATABLE AND ARTICULATABLE SURGICAL END        EFFECTOR;    -   U.S. patent application Ser. No. 16/885,838, entitled        ELECTROSURGICAL INSTRUMENT WITH ASYNCHRONOUS ENERGIZING        ELECTRODES;    -   U.S. patent application Ser. No. 16/885,851, entitled        ELECTROSURGICAL INSTRUMENT WITH ELECTRODES BIASING SUPPORT;    -   U.S. patent application Ser. No. 16/885,860, entitled        ELECTROSURGICAL INSTRUMENT WITH FLEXIBLE WIRING ASSEMBLIES;    -   U.S. patent application Ser. No. 16/885,866, entitled        ELECTROSURGICAL INSTRUMENT WITH VARIABLE CONTROL MECHANISMS;    -   U.S. patent application Ser. No. 16/885,870, entitled        ELECTROSURGICAL SYSTEMS WITH INTEGRATED AND EXTERNAL POWER        SOURCES;    -   U.S. patent application Ser. No. 16/885,873, entitled        ELECTROSURGICAL INSTRUMENTS WITH ELECTRODES HAVING ENERGY        FOCUSING FEATURES;    -   U.S. patent application Ser. No. 16/885,879, entitled        ELECTROSURGICAL INSTRUMENTS WITH ELECTRODES HAVING VARIABLE        ENERGY DENSITIES;    -   U.S. patent application Ser. No. 16/885,881, entitled        ELECTROSURGICAL INSTRUMENT WITH MONOPOLAR AND BIPOLAR ENERGY        CAPABILITIES;    -   U.S. patent application Ser. No. 16/885,888, entitled        ELECTROSURGICAL END EFFECTORS WITH THERMALLY INSULATIVE AND        THERMALLY CONDUCTIVE PORTIONS;    -   U.S. patent application Ser. No. 16/885,893, entitled        ELECTROSURGICAL INSTRUMENT WITH ELECTRODES OPERABLE IN BIPOLAR        AND MONOPOLAR MODES;    -   U.S. patent application Ser. No. 16/885,900, entitled        ELECTROSURGICAL INSTRUMENT FOR DELIVERING BLENDED ENERGY        MODALITIES TO TISSUE;    -   U.S. patent application Ser. No. 16/885,917, entitled CONTROL        PROGRAM ADAPTATION BASED ON DEVICE STATUS AND USER INPUT;    -   U.S. patent application Ser. No. 16/885,923, entitled CONTROL        PROGRAM FOR MODULAR COMBINATION ENERGY DEVICE; and    -   U.S. patent application Ser. No. 16/885,931, entitled SURGICAL        SYSTEM COMMUNICATION PATHWAYS.

Before explaining various forms of surgical instruments in detail, itshould be noted that the illustrative forms are not limited inapplication or use to the details of construction and arrangement ofparts illustrated in the accompanying drawings and description. Theillustrative forms may be implemented or incorporated in other forms,variations and modifications, and may be practiced or carried out invarious ways. Further, unless otherwise indicated, the terms andexpressions utilized herein have been chosen for the purpose ofdescribing the illustrative forms for the convenience of the reader andare not for the purpose of limitation thereof.

Further, it is understood that any one or more of thefollowing-described forms, expressions of forms, examples, can becombined with any one or more of the other following-described forms,expressions of forms, and examples.

Various forms are directed to improved ultrasonic and/or electrosurgical(RF) instruments configured for effecting tissue treating, dissecting,cutting, and/or coagulation during surgical procedures. In one form, acombined ultrasonic and electrosurgical instrument may be configured foruse in open surgical procedures, but has applications in other types ofsurgery, such as minimally invasive laparoscopic, orthoscopic, orthoracoscopic procedures, for example, non-invasive endoscopicprocedures, either in hand held or and robotic-assisted procedures.Versatility is achieved by selective application of multiple energymodalities simultaneously, independently, sequentially, or combinationsthereof. For example, versatility may be achieved by selective use ofultrasonic and electrosurgical energy (e.g., monopolar or bipolar RFenergy) either simultaneously, independently, sequentially, orcombinations thereof.

In one aspect, the present disclosure provides an ultrasonic surgicalclamp apparatus comprising an ultrasonic blade and a deflectable RFelectrode such that the ultrasonic blade and deflectable RF electrodecooperate to effect sealing, cutting, and clamping of tissue bycooperation of a clamping mechanism of the apparatus comprising the RFelectrode with an associated ultrasonic blade. The clamping mechanismincludes a pivotal clamp arm which cooperates with the ultrasonic bladefor gripping tissue therebetween. The clamp arm is preferably providedwith a clamp tissue pad (also known as “clamp arm pad”) having aplurality of axially spaced gripping teeth, segments, elements, orindividual units which cooperate with the ultrasonic blade of theend-effector to achieve the desired sealing and cutting effects ontissue, while facilitating grasping and gripping of tissue duringsurgical procedures.

In one aspect, the end-effectors described herein comprise an electrode.In other aspects, the end-effectors described herein comprisealternatives to the electrode to provide a compliant coupling of RFenergy to tissue, accommodate pad wear/thinning, minimize generation ofexcess heat (low coefficient of friction, pressure), minimize generationof sparks, minimize interruptions due to electrical shorting, orcombinations thereof. The electrode is fixed to the clamp jaw at theproximal end and is free to deflect at the distal end. Accordingly,throughout this disclosure the electrode may be referred to as acantilever beam electrode or as a deflectable electrode.

In other aspects, the end-effectors described herein comprise a clamparm mechanism configured to apply high pressure between a pad and anultrasonic blade to grasp and seal tissue, maximize probability that theclamp arm electrode contacts tissue in limiting or difficult scenarios,such as, for example, thin tissue, tissue under lateral tension, tissuetenting/vertical tension especially tenting tissue away from clamp arm.

In other aspects, the end-effectors described herein are configured tobalance match of surface area/current densities between electrodes,balance and minimize thermal conduction from tissue interface, such as,for example, impacts lesion formation and symmetry, cycle time, residualthermal energy.

In other aspects, the end-effectors described herein are configured tominimize sticking, tissue adherence (minimize anchor points) and maycomprise small polyimide pads.

In various aspects, the present disclosure provides a combinationultrasonic/bipolar RF energy surgical device. The combinationultrasonic/bipolar RF energy surgical device comprises an end-effector.The end-effector comprises a clamp arm and an ultrasonic blade. Theclamp arm comprises a movable clamp jaw, a compliant polymeric pad, andat least one bipolar RF electrode. The at least one electrode is coupledto a positive pole of an RF generator and the ultrasonic blade iscoupled to the negative pole of the RF generator. The ultrasonic bladeis acoustically coupled to an ultrasonic transducer stack that is drivenby an ultrasonic generator. In various aspects, the end-effectorcomprises electrode biasing mechanisms.

In one general aspect, the present disclosure is directed to a methodfor using a surgical device comprising a combination of ultrasonic andadvanced bipolar RF energy with a movable RF electrode on at least onejaw of an end-effector. The movable RF electrode having a variablebiasing force from a proximal end to a distal end of the movable RFelectrode. The movable RF electrode being segmented into discreteportions than can be put in electrical communication or isolated fromeach other. The movable RF electrode being made of a conductive orpartially conductive material. It will be appreciated that any of theend effectors described in this disclosure may be configured with anelectrode biasing mechanism.

In one aspect, the present disclosure provides a limiting electrodebiasing mechanism to prevent ultrasonic blade to electrode damage.Generally, in various aspects, the present disclosure provides anend-effector for use with a ultrasonic/RF combination device, where theend-effector comprises an electrode. In one aspect, the combinationultrasonic/bipolar RF energy surgical device comprises an electrodebiasing mechanism. In one aspect, the limiting electrode biasingmechanism is configured to prevent or minimize ultrasonic blade toelectrode damage. The electrode is fixed to the clamp jaw at theproximal end and is free to deflect at the distal end. Accordingly,throughout this disclosure the electrode may be referred to as acantilever beam electrode or as a deflectable electrode.

In various aspects, the present disclosure provides an electrodecantilever beam fixated at only one end comprising a biasing thresholdmechanism. In one aspect, the deflectable cantilever electrode isconfigured for combination ultrasonic/bipolar RF energy surgicaldevices.

In one aspect, the combination ultrasonic/RF energy surgical devicecomprises an ultrasonic blade, a clamp arm, and at least one electrodewhich crosses over the ultrasonic blade. In one aspect, the electrode isconfigured to be deflectable with respect to the clamp arm and includesfeatures to change the mechanical properties of the tissue undercompression between the electrode and the ultrasonic blade. In anotheraspect, the electrode includes a feature to prevent inadvertent contactbetween the electrode and the ultrasonic blade to prevent or minimizeultrasonic blade to electrode damage.

In various aspects, the electrode comprises a metallic spring elementattached at a proximal end of the clamp jaw of the end-effector. Themetallic spring element defines openings for receives therethrough oneor more clamp arm pads (also known as “tissue pads” or “clamp tissuepads”) and comprises integrated minimum gap elements. This configurationof the electrode provides a method of preventing tissue fromaccumulating around the biasing mechanism that can impact theperformance of the electrode. This configuration also minimizes thebinding between the wear pads and the biasing spring, increases thestrength of the electrode to clamp arm connection, minimizes inadvertentrelease of the clamp arm pads by attaching the polyimide pads to theelectrode, and balance matches the surface area/current densitiesbetween electrodes. The electrode is fixed to the clamp jaw at theproximal end and is free to deflect at the distal end. Accordingly,throughout this disclosure the electrode is deflectable and may bereferred to as a cantilever beam electrode or deflectable electrode.

FIGS. 1-9 illustrate one aspect of an end-effector comprising adeflectable/cantilever electrode configured for use with a combinationultrasonic/bipolar RF energy device, according to at least one aspect ofthe present disclosure. FIG. 1 is a perspective view of a clamp arm 1000portion of an end-effector for use with a combined ultrasonic/RF device,according to at least one aspect of the present disclosure. Forconciseness and clarity of disclosure, the ultrasonic blade, whichfunctions as the other clamp arm of the end-effector is not shown. Theend-effector is configured such that the ultrasonic blade is one pole ofthe bipolar RF circuit and the clamp arm 1000 is the opposite pole. Aconsistent RF electrode gap is maintained between the clamp arm 1000 andthe ultrasonic blade to prevent the ultrasonic blade from contacting theelectrode resulting in blade breakage or a short circuit. Tissue undertreatment is clamped and compressed between the clamp arm 1000 and theultrasonic blade.

The clamp arm 1000 includes a frame 1002, an electrode 1004, at leastone small electrically nonconductive gap pad 1006, at least one largeelectrically nonconductive gap pad 1008, at least one electricallynonconductive clamp arm pad 1010. In one aspect, the small and large gappads 1006, 1008 are configured to set a gap between the electrode 1004and the ultrasonic blade. The clamp arm pad 1010 is configured to grasptissue between the clamp arm 1000 and the ultrasonic blade to assistwith sealing and cutting of the tissue. In other aspects, the small andlarge nonconductive gap pads may be swapped. In other aspects, thenonconductive gap pads are simply sized differently regardless of therelative size difference between the nonconductive gap pads.

Pivotal movement of the clamp arm 1000 with respect to the end-effectoris effected by the provision of at least one, and preferably a pair of,lever portions 1012 of the clamp arm 1000 frame 1002 at a proximal end1014 thereof. The lever portions 1012 are positioned on respectiveopposite sides of an ultrasonic waveguide and end-effector, and are inoperative engagement with a drive portion of a reciprocable actuatingmember. Reciprocable movement of the actuating member, relative to anouter tubular sheath and the ultrasonic waveguide, thereby effectspivotal movement of the clamp arm 1000 relative to the end-effectorabout pivot points 1016. The lever portions 1012 can be respectivelypositioned in a pair of openings defined by the drive portion, orotherwise suitably mechanically coupled therewith, whereby reciprocablemovement of the actuating member acts through the drive portion andlever portions 1012 to pivot the clamp arm 1000.

FIG. 2 is an exploded view of the clamp arm 1000 shown in FIG. 1,according to at least one aspect of the present disclosure. In variousaspects, the electrode 1004 is made of a metallic spring materialattached at a proximal end 1014 of the frame 1002 of the clamp arm 1000such that the electrode 1004 can deflect. The metallic spring electrode1004 defines openings 1018 for receiving therethrough elements of theclamp arm pad 1010 and defines additional openings 1020, 1021 forreceiving the gap pads 1006, 1008 to set a minimum gap between theelectrode 1004 and the ultrasonic blade. At least one of the gap pads1006 is disposed on a distal end 1022 of the electrode 1004. The gappads 1006, 1008 are thus integrated with the electrode 1004. In thisconfiguration, the electrode 1004 prevents tissue from accumulatingaround the biasing mechanism, e.g., cantilevered spring, that can impactthe performance of the electrode 1004. This configuration also minimizesthe binding between the wearable clamp arm pads 1010 and the biasingspring electrode 1004, increases the strength of the electrode 1004 tothe clamp arm connection, minimizes inadvertent release of the clamp armpads 1018 by attaching the gap pads 1006, 1008 to the electrode 1004,and balance matches the surface area/current densities betweenelectrodes. The electrode 1004 is attached to the frame 1002 by twoprotrusions 1024. The electrode protrusions 1024 are attached to theproximal end 1014 of the frame 1002 as shown in FIGS. 3 and 4.

FIGS. 3 and 4 are perspective views of the frame 1002, according to atleast one aspect of the present disclosure. These views illustrate theconnection surfaces 1026 on the proximal end 1014 of the fame 1002 forattaching the proximal end of the electrode 1004 to the frame 1002. Inone aspect, the electrode protrusions 1024 are welded to the connectionsurfaces 1026 of the frame 1002 such that the electrode 1004 behaves ina deflectable manner.

FIG. 5 is a perspective view of the electrode 1004, according to atleast one aspect of the present disclosure. This view illustrates thebias in the electrode 1004 made of spring material as indicated by thecurvature of the electrode 1004 along a longitudinal length. Theopenings 1018, 1020, 1021 for receiving the gap pads 1006, 1008 and theclamp arm pads 1010. In one aspect, the electrode 1004 has a thickness“d” of 0.010″ and may be selected within a range of thicknesses of0.005″ to 0.015″, for example. With reference also to FIGS. 8 and 9, theopenings 1020 are sized and configured to receive a protrusion 1036defined on a bottom portion of the gap pads 1006.

FIG. 6 is a perspective view of the clamp arm pad 1010, according to atleast one aspect of the present disclosure. The clamp arm pad 1010comprises a plurality of clamp arm elements 1032 protruding from abackbone 1030. Throughout this disclosure, the clamp arm elements 1032also are referred to as “teeth.” In one aspect, the clamp arm pad 1010defines apertures 1028 in a position where the gap pads 1006 are locatedon the electrode 1004. With reference also to FIGS. 8 and 9, theapertures 1028 defined by the clamp arm pad 1010 are sized andconfigured to receive the protrusion 1036 defined on a bottom portion ofthe gap pads 1006. In one aspect, the clamp arm pad 1010 material issofter than the gap pad 1006, 1008 material. In one aspect, the clamparm pad 1010 is made of a non-stick lubricious material such aspolytetrafluoroethylene (PTFE) or similar synthetic fluoropolymers oftetrafluoroethylene. PTFE is a hydrophobic, non-wetting, high densityand resistant to high temperatures, and versatile material and non-stickproperties. In contrast, the gap pads 1006, 1008 are made of a polyimidematerial, and in one aspect, is made of a durable high-performancepolyimide-based plastic known under the tradename VESPEL andmanufactured by DuPont or other suitable polyimide, polyimide polymeralloy, or PET (Polyethylene Terephthalate), PEEK (Polyether EtherKetone), PEKK (Poly Ether Ketone Ketone) polymer alloy, for example.Unless otherwise noted hereinbelow, the clamp arm pads and gap padsdescribed hereinbelow are made of the materials described in thisparagraph.

FIG. 7 is a perspective top view of the large gap pad 1008, according toat least one aspect of the present disclosure. The large gap pad 1008comprises a protrusion 1034 sized and configured to fit within theopening 1021 at the proximal end 1014 of the electrode 1004. FIG. 8 is aperspective top view of the small gap pad 1006, according to at leastone aspect of the present disclosure. FIG. 9 is a perspective bottomview of the small gap pad 1006 shown in FIG. 8. As shown in FIGS. 8 and9, the small gap pads 1006 include a protrusion 1036 at the bottomportion sized and configured to be received within the openings 1020defined by the electrode 1004 and the apertures 1028 defined by theclamp arm pad 1010. The small and large gap pads 1006, 1008 are made ofa polyimide material, and in one aspect, is made of a durablehigh-performance polyimide-based plastic known under the tradenameVESPEL and manufactured by DuPont. The durability of the polyimidematerial ensures that the electrode gap remains relatively constantunder normal wear and tear.

In one aspect, the present disclosure also provides additionalend-effector configurations for combination ultrasonic and bipolar RFenergy devices. This portion of the disclosure provides end-effectorconfigurations for use in combination ultrasonic and bipolar RF energydevices. In these configurations, the end-effector maintains aconsistent gap between the RF electrode gap and the ultrasonic blade,which functions as one pole of the bipolar RF circuit, and the clamparm, which functions as the opposite pole of the bipolar RF circuit. Inconventional end-effector configurations, the electrode gap is set by asoft PTFE clamp arm pad which may be subject to wear during surgery.When the clamp arm pad wears through, the ultrasonic blade can contactthe electrode resulting in blade breakage or an electrical shortcircuit, both of which are undesirable.

To overcome these and other limitations, various aspects of the presentdisclosure incorporate a deflectable RF electrode in combination with aclamp arm pad comprising a non-stick lubricious compliant (e.g., PTFE)pad fixed to the clamp arm. The RF electrode contains wear-resistant,electrically nonconductive pads which contact the blade to set theblade-to-electrode gap. The compliant clamp arm pad extends throughopenings defined by the electrode and reacts to the clamping force fromthe ultrasonic blade. As the compliant clamp arm pad wears, theelectrode deflects to maintain a constant gap between the blade and theelectrode. Such configuration provides a consistent gap between theelectrode and the ultrasonic blade throughout the life of the device,prevents shorting and ultrasonic blade breakage, which can occur whenthe ultrasonic blade touches the electrode, and enables the electrodematerial to be positioned directly on the side that is opposite theultrasonic blade to improve sealing performance. The electrode is fixedto the clamp jaw at the proximal end and is free to deflect at thedistal end. Accordingly, throughout this disclosure the electrode may bereferred to as a cantilever beam electrode or deflectable electrode.

In one aspect, the present disclosure provides asymmetric cooperation ofthe clamp arm/electrode/pad to effect the ultrasonic blade-RF electrodeinteraction. In one aspect, the present disclosure provides a shortenedclamp arm. FIGS. 10-12 illustrate an effector comprising a shortenedclamp arm for deflectable/cantilever electrode applications, accordingto various aspects of the present disclosure. In one aspect, theend-effector is configured for asymmetric cooperation of the clamp arm,electrode, and clamp arm pad to effect the ultrasonic blade/RF electrodeinteraction. The electrode is adapted and configured for use with acombination ultrasonic/bipolar RF energy surgical device and isdeflectable under load, where the electrode is one pole of the bipolarRF circuit and the ultrasonic blade is the opposite pole of the bipolarRF circuit.

In one aspect, a distal end of the clamp arm is shortened and a lengthof the clamp arm pad is kept the same length such that a distal end ofthe clamp arm pad extends beyond the distal end of the clamp arm. Thiswould allow the electrode to hyper-extend to minimize potential forelectrically shorting the distal end of the clamp arm. It also may havethe benefit of extending the life of the clamp arm pad because of theadditional exposed clamp arm pad material to be worn through. Thisconfiguration also can eliminate the use of the distal and middle gapsetting clamp arm pads, previously referred to herein, for example, aswear resistant clamp arm pads for setting and maintaining a gap betweenthe electrode and the ultrasonic blade.

FIG. 10 is a side view of an end-effector 1680 comprising a shortenedclamp arm 1682, an ultrasonic blade 1684, an electrode 1686, and a clamparm pad 1688, according to at least one aspect of the presentdisclosure. FIG. 11 is a top view of the end-effector 1680. As shown inFIGS. 10-11, the ultrasonic blade 1684 and the electrode 1686 aresubstantially the same length. The clamp arm 1682 is shortened to allowthe electrode 1686 to overextend to prevent an electrical short circuit.In one aspect, a gap setting pad 1690 is provided at a proximal end 1692of the end-effector 1680.

FIG. 12 illustrates a clamp arm 1700 comprising a clamp jaw 1702, anelectrode 1704, and a clamp arm pad 1706, according to at least oneaspect of the present disclosure. Free up space distally on clamp arm.The clamp arm 1700 is configured for use with an end-effector comprisingan ultrasonic blade as disclosed in other sections herein. Thisconfiguration frees up space distally 1708 on the clamp jaw 1702. Theclamp arm pad 1706 (e.g., PTFE) is fully supported underneath, but spaceis freed in the t-slot region and on the side walls to allow for moreclamp arm pad 1706 burn through and further deflection of the electrode1704 away from the ultrasonic blade (not shown).

In one aspect, the present disclosure provides an end-effector thatemploys the thermal behavior of the pad to deflect the electrode. In oneaspect, the length of the clamp arm pad may be the same length as theultrasonic blade and as the clamp arm pad expands or changes shape dueto pressure or heat, the thermal expansion properties of the clamp armpad material (e.g., PTFE) can be used to deflect the electrode out ofthe path of the ultrasonic blade.

In one aspect, a non-biased electrode and pad are provided. Thenon-biased but deflectable pad varies in position with respect to theclamp arm as the pad wears. The non-biased electrode is configured tominimize contact between the ultrasonic blade and the RF electrode. Theclamp arm pad comprises a feature for securing the electrode to theclamp arm pad. In one aspect, as the height of the clamp arm pad wearsor is cut through, the height of the electrode with respect to the clamparm is progressively adjusted. In another aspect, once the clamp arm ismoved away from the ultrasonic blade the electrode remains in its newposition. The electrode is fixed to the clamp arm at the proximal endand is free to deflect at the distal end. Accordingly, throughout thisdisclosure the electrode may be referred to as a cantilever beamelectrode or as a deflectable electrode.

Configurations of end-effectors comprising a deflectable/cantileverelectrode described hereinabove with respect to FIGS. 1-12 may becombined with a biased electrode as described hereinbelow with respectto FIGS. 13-18.

In one aspect, the present disclosure provides an end-effector for acombination ultrasonic/bipolar RF energy surgical device that employspressure or clamp jaw compression to adjust the height of the electrodeas the clamp arm pad wears. In one aspect, the clamp arm pad follows theclamp arm biased electrode with wearable stops. In one aspect, the clamparm pad contains a feature for securing the electrode to the pad. As thepad height wears or is cut through, the electrode height with respect tothe clamp arm is progressively adjusted. Once the clamp arm is movedaway from the ultrasonic blade, the electrode stays in its new position.

Achieving sufficient clamp arm pad life on a combinationultrasonic/bipolar RF energy surgical device requires maintaining asufficiently small yet non-zero clamp arm pad-to-electrode gapthroughout the life of the instrument to provide desirable ultrasonicand bipolar RF tissue effects. The electrode is adapted and configuredfor use with a combination ultrasonic/bipolar RF energy surgical deviceand is deflectable under load, where the electrode is one pole of thebipolar RF circuit and the ultrasonic blade is the opposite pole of thebipolar RF circuit.

The existing (seed) electrode is a flat electrode, which is practicallyhorizontal or parallel to the clamp arm in the free state (no load). Theelectrode is fixed to the clamp arm at the proximal end and is free todeflect at the distal end. Accordingly, throughout this disclosure theelectrode may be referred to as a cantilever beam electrode or as adeflectable/cantilever electrode. When clamped on tissue, the tissueloads the electrode, causing it to deflect toward the clamp arm.

In one aspect, the electrode “follows” the pad as it wears. In thisaspect, the electrode is biased toward the clamp arm in the free state(whether by being a formed/curved electrode, or by attaching/welding theelectrode non-parallel to the clamp arm) using any suitable fasteningtechnique such as welding, laser welding, brazing, soldering, pressing,among other fastening techniques. Wearable stop features (on the pad orelsewhere) keep the electrode away from the clamp arm, until said stopfeatures are worn away during use. Once worn away, the electrode is ableto approach the clamp arm. These features could be tooth or ratchetshaped, a vertical taper, or other.

In one aspect, the present disclosure provides a deflectable/cantileverelectrode, wherein in a free state, the electrode is biased toward clamparm and may attached at an angle and made of a preformed curve using anysuitable fastening technique such as welding, laser welding, brazing,soldering, pressing, among other fastening techniques.

In one aspect, the present disclosure provides an end-effector with adeflectable/cantilever electrode comprising wearable stop features toprevent the electrode from reaching or contacting the clamp arm. As thestop features wear, the electrode moves toward the clamp arm until itreaches the next stop. In one aspect, the stop features wearsimultaneously with the clamp arm pad to maintain the appropriate gapbetween the clamp arm pad and the electrode. The features may beentirely separate from the clamp arm pad. The features can be configuredto withstand clamping loads, but wear away due to heat (melting/flowing)or abrasion. Possible examples include teeth on one or more clamp armpads (PTFE, polyimide, or other) and tapered profile on one or moreclamp arm pads (PTFE, polyimide, or other).

FIG. 13 illustrates an end-effector clamp arm 1710 comprising a clampjaw 1712, an electrode 1714, and a clamp arm pad 1716, according to atleast one aspect of the present disclosure. The clamp arm 1710 isconfigured for use with an end-effector comprising an ultrasonic blade(not shown) as described throughout this disclosure. The clamp arm 1710also comprises a wear resistant gap pad 1717 to set a gap between theelectrode 1714 and the ultrasonic blade. As shown, in the free state,the electrode 1714 is biased in a level or horizontal 1718 orientation.The electrode 1714 is fixed to the clamp jaw 1712 at the proximal endand is free to deflect at the distal end. Accordingly, throughout thisdisclosure the electrode 1714 may be referred to as a cantilever beamelectrode or as a deflectable electrode.

FIG. 14 illustrates an end-effector clamp arm 1720 comprising a clampjaw 1722, an electrode 1724, and a clamp arm pad 1726, according to atleast one aspect of the present disclosure. The clamp arm 1720 isconfigured for use with an end-effector comprising an ultrasonic blade(not shown) as described throughout this disclosure. The clamp arm 1720also comprises a wear resistant gap pad 1727 to set a gap between theelectrode 1724 and the ultrasonic blade. As shown, in the free state,the electrode 1724 is configured pre-formed, bent, or is otherwisebiased toward the clamp jaw 1722 along line 1728 away from thehorizontal 1718 orientation. The electrode 1724 is fixed to the clamparm 1720 at the proximal end and is free to deflect at the distal end.Accordingly, throughout this disclosure the electrode 1724 may bereferred to as a cantilever beam electrode or as a deflectableelectrode. To prevent the biased electrode 1724 from bending toward theclamp jaw 1722 under the biasing force, the clamp arm 1720 furthercomprises a retainer to prevent the biased electrode 1724 from bendingtoward the clamp jaw 1722 and maintaining the biased electrode 1724 in asubstantially flat configuration (e.g., parallel, level, or horizontal)relative to the ultrasonic blade. Examples of retainers such as aretainer tooth 1738 and a retainer wall 1760 with a tapered profile aredescribed below in FIGS. 15-18.

FIG. 15 illustrates an end-effector clamp arm 1730 comprising a clampjaw 1732, an electrode 1734, and a clamp arm pad 1736, according to atleast one aspect of the present disclosure. The clamp arm 1730 isconfigured for use with an end-effector comprising an ultrasonic blade(not shown) as described throughout this disclosure. The clamp arm 1730also comprises a wear resistant gap pad 1737 to set a gap between theelectrode 1744 and the ultrasonic blade. In the free state, theelectrode 1734 is configured pre-formed curved, bent, or otherwisebiased toward the clamp jaw 1732. However, a retainer tooth 1738, orsimilar feature, is provided on the clamp arm pad 1736 to prevent theelectrode 1734 from springing in toward the clamp jaw 1732. In FIG. 16,when the bottom retainer tooth 1738 is worn away, the electrode 1734 canmove toward the clamp jaw 1732 due to the pre-formed curve, according toat least one aspect of the present disclosure. The electrode 1734 isfixed to the clamp arm 1730 at the proximal end and is free to deflectat the distal end. Accordingly, throughout this disclosure the electrode1734 may be referred to as a cantilever beam electrode or as adeflectable electrode.

FIG. 17 illustrates an end-effector clamp arm 1750 comprising a clampjaw 1752, an electrode 1754, and a clamp arm pad 1756, according to atleast one aspect of the present disclosure. The clamp arm 1750 isconfigured for use with an end-effector comprising an ultrasonic blade(not shown) as described throughout this disclosure. The clamp arm 1750also comprises a wear resistant gap pad 1757 to set a gap between theelectrode 1754 and the ultrasonic blade. In the free state, theelectrode 1754 is configured pre-formed with a curve, bent, or otherwisebiased toward 1758 the clamp jaw 1752. However, a retainer wall 1760having a tapered profile, or similar feature, is provided on the clamparm pad 1756 to prevent the electrode 1754 from springing in toward theclamp jaw 1752.

In FIG. 18, when the tapered profile retainer wall 1760 is worn away,there is sufficient melting/flowing away from the tapered profileretainer wall 1760 region to allow the electrode 1754 to move toward theclamp jaw 1752 due to the pre-formed curve, according to at least oneaspect of the present disclosure. The electrode 1754 is fixed to theclamp jaw 1752 at the proximal end and is free to deflect at the distalend. Accordingly, throughout this disclosure the electrode 1754 may bereferred to as a cantilever beam electrode or as a deflectableelectrode.

In one aspect, the present disclosure provides an end-effector for acombination ultrasonic/bipolar RF energy surgical device that employs aconstant pressure distribution biasing mechanism. In one aspect, theend-effector includes an elastic compressible support for mounting andinsulating a deflectable electrode. In one aspect, a hollow honeycomb orchambered elastomer support attachment cushion can be employed to allowall or part of the electrode attached to it to deflect but be biasedtowards the ultrasonic blade. This configuration could provide the addedbenefit of thermally insulating the electrode from the rest of themetallic clamp jaw. This would also provide an elastomer “curtain”around the electrode to minimize tissue accumulation behind theelectrode. In one aspect, a non-strut deflectable geometry for theelastomer cells will enable the deflection force to be held constantover a predefined range of deflections. The electrode is adapted andconfigured for use with a combination ultrasonic/bipolar RF energysurgical device and is deflectable under load, where the electrode isone pole of the bipolar RF circuit and the ultrasonic blade is theopposite pole of the bipolar RF circuit.

The above configuration prevents lateral skew of the electrode undercompression to prevent shorting. Further, the deflectable electrode isaffixed to the elastomer and the elastomer is affixed to the metallicclamp arm. The solid height of the spring is limited from drivingallowable compression while maintaining as much metallic clamp arm aspossible. Thermal conduction from tissue interface is balanced andminimizes —impacts lesion formation and symmetry, cycle time, andresidual thermal energy.

FIG. 19 illustrates a clamp arm 1770 comprising a clamp jaw 1772, anelectrode 1774, and a clamp arm pad 1776, according to at least oneaspect of the present disclosure. The clamp arm 1770 is configured foruse with an end-effector comprising an ultrasonic blade (not shown) asdescribed throughout this disclosure. A partial skirt 1778 is providedaround a distal end 1780 of the clamp arm 1770 to surround the distalclamp arm pad 1776. As the clamp arm pad 1776 (e.g., PTFE) heats anddeforms, the clamp arm pad 1776 is contained within the distal skirt1778 to prevent the clamp arm pad 1776 from expanding laterally. Theelectrode 1774 has a higher bias at the distal end 1780 than theproximal end 1782.

FIG. 20 illustrates a magnified view of the distal end 1780 of the clamparm 1770 with the clamp arm pad 1776 removed to expose the distal skirt1778, according to at least one aspect of the present disclosure. Theelectrode 1774 is fixed to the clamp arm 1770 at the proximal end and isfree to deflect at the distal end. Accordingly, throughout thisdisclosure the electrode 1774 may be referred to as a cantilever beamelectrode or as a deflectable electrode.

In one aspect, electrode height-setting members are provided to engagewith the electrode 1774 at different times relative to the clamp arm pad1776 as it wears. In one aspect, height-setting members embedded in theclamp arm pad 1776 wear at different rates (but less wear relative tothe PTFE clamp arm pads 1776). In another aspect, the height-settingmembers have different heights such that they cause a purposeful“bottoming out” of the electrode 1774 as the clamp arm pad 1776 wears.

In one aspect, the present disclosure provides an end-effector for acombination ultrasonic/bipolar RF energy surgical device that employsthermal expansion or thermal changes in the pad to move the supportfeature securing the electrode to the pad as the pad wears. In variousaspects, as the clamp arm pad heats up during use the support componentor feature holding the electrode in its current location melts/moves,which in-turn moves the support component or feature for the electrodeholding feature effectively adjusting the height/position of theelectrode with respect to the clamp arm. The electrode is adapted andconfigured for use with a combination ultrasonic/bipolar RF energysurgical device and is deflectable under load, where the electrode isone pole of the bipolar RF circuit and the ultrasonic blade is theopposite pole of the bipolar RF circuit.

In one aspect, the present disclosure provides an end-effector for acombination ultrasonic/bipolar RF energy surgical device where the shapeof the clamp arm pad or support location changes based on thermaladjustment of the clamp arm pad due to pad wear. FIGS. 70A-70Cillustrate an end-effector 1790 comprising a clamp arm 1792, anelectrode 1794, a clamp arm pad 1796, and an ultrasonic blade 1798,where the clamp arm pad 1796 comprises support elements 1800 to supportthe electrode 1794, according to at least one aspect of the presentdisclosure. Thermal changes in the clamp arm pad 1796 cause theelectrode 1794 support elements 1800 to change, effectively adjustingthe height (h) of the electrode 1794 relative to the clamp arm 1792 andthe gap (g) between the ultrasonic blade 1798 and the electrode 1794remains in a constant range. The support elements 1800 shown here astabs (tab1, tab2, tab3), but other elements may be employed. Theelectrode 1794 is fixed to the clamp jaw 1792 at the proximal end and isfree to deflect at the distal end. Accordingly, throughout thisdisclosure the electrode 1794 may be referred to as a cantilever beamelectrode or as a deflectable electrode.

FIG. 21A shows a new clamp arm pad 1796 and an electrode 1794 supportedby support element 1800 (tab1, tab2, tab3). FIG. 21B shows the clamp armpad 1796 heating up an causes the first row of support elements 1800(tab1) to melt and wear away causing the electrode 1794 to drop inheight (h). FIG. 21C shows that as the clamp arm pad 1796 continuesheating and wearing, the second row support elements 1800 (tab2) to meltand wear away causing the height (h) of the electrode 1794 to furtherdrop down.

Configurations of end-effectors comprising a deflectable/cantileverelectrode described hereinabove with respect to FIGS. 1-12 may becombined with a flexible electrode disposed above a lattice cushion anda plurality of hard spacers to set a gap between the flexible electrodeand the ultrasonic blade as described hereinbelow with respect to FIGS.22-24.

Configurations of a biased electrode as described hereinabove withrespect to FIGS. 13-21 may be combined with a flexible electrodedisposed above a lattice cushion and a plurality of hard spacers to seta gap between the flexible electrode and the ultrasonic blade asdescribed hereinbelow with respect to FIGS. 22-24.

Configurations of end-effectors comprising a deflectable/cantileverelectrode described hereinabove with respect to FIGS. 1-12 incombination with a biased electrode as described hereinabove withrespect to FIGS. 13-21 may be combined with a flexible electrodedisposed above a lattice cushion and a plurality of hard spacers to seta gap between the flexible electrode and the ultrasonic blade asdescribed hereinbelow with respect to FIGS. 22-24.

FIGS. 22-24 illustrate an end-effector 1810 comprising a clamp arm 1812,an ultrasonic blade 1814, a lattice cushion 1816, a flexible electrode1818 disposed above the lattice cushion 1816, and a plurality of hardspacers 1820 to set a gap between the flexible electrode 1818 and theultrasonic blade 1814, according to at least one aspect of the presentdisclosure. FIG. 24 is an exploded view of the end-effector 1810 shownin FIGS. 22-23. A clamp arm pad 1822 is disposed inside a slot 1825formed within the lattice cushion 1816. The lattice cushion 1816 acts asa spring-like element. The hard spacers 1820 are used to set a gapbetween the flexible electrode 1818 and the ultrasonic blade 1814.

In FIG. 22 the clamp arm 1812 is open and tissue 1824 of non-uniformthickness (T_(1a), T_(2a), T_(1a)) is disposed over the flexibleelectrode 1818. In FIG. 23 the clamp arm 1812 is closed to compress thetissue 1824. The lattice cushion 1816 on the clamp arm 1812 results inconsistent tissue 1824 (T_(1b), T_(2b), T_(3b)) compression acrossvariable thickness tissue 1824 (T_(1a), T_(2a), T_(3a)), such that:

$\frac{T_{1a}}{T_{1b}} = {\frac{T_{2a}}{T_{2b}} = \frac{T_{3a}}{T_{3b}}}$

Additional background disclosure may be found in EP3378427,WO2019/006068, which are herein incorporated by reference in theirentirety.

In one aspect, the present disclosure provides an end-effector for acombination ultrasonic/bipolar RF energy surgical device with means forinsuring distal tip contact with bias using a zero gap bipolar RF energysystem. In various aspects, the present disclosure provides adeflectable electrode for a combination ultrasonic/bipolar RF energysurgical device with a higher distal bias than proximal bias. In oneaspect, the present disclosure provides a combination energy devicecomprising a bipolar electrode that is deflectable with respect to theclamp arm. The combination energy device comprises features to changethe mechanical properties of the tissue compression proximal to distalto create a more uniform or differing pattern of pressure than due tothe clamping forces alone. In one aspect, the present disclosureprovides a non-linear distal distributing mechanism and in anotheraspect the present disclosure provides electrical non-lineardistribution of energy density. The electrode is adapted and configuredfor use with a combination ultrasonic/bipolar RF energy surgical deviceand is deflectable under load, where the electrode is one pole of thebipolar RF circuit and the ultrasonic blade is the opposite pole of thebipolar RF circuit.

Configurations of end-effectors comprising a deflectable/cantileverelectrode described hereinabove with respect to FIGS. 1-12 may becombined with a conductive polymer clamp arm pad as describedhereinbelow with respect to FIGS. 25-39.

Configurations of a biased electrode as described hereinabove withrespect to FIGS. 13-18 may be combined with a conductive polymer clamparm pad as described hereinbelow with respect to FIGS. 25-39.

Configurations of a flexible electrode disposed above a lattice cushionand a plurality of hard spacers to set a gap between the flexibleelectrode and the ultrasonic blade as described hereinabove with respectto FIGS. 22-24 may be combined with a conductive polymer clamp arm padas described hereinbelow with respect to FIGS. 25-39.

Configurations of a biased electrode as described hereinabove withrespect to FIGS. 13-18 may be combined with a flexible electrodedisposed above a lattice cushion and a plurality of hard spacers to seta gap between the flexible electrode and the ultrasonic blade asdescribed hereinabove with respect to FIGS. 22-24 may be combined with aconductive polymer clamp arm pad as described hereinbelow with respectto FIGS. 25-39.

Configurations of a biased electrode as described hereinabove withrespect to FIGS. 13-18 may be combined with a flexible electrodedisposed above a lattice cushion and a plurality of hard spacers to seta gap between the flexible electrode and the ultrasonic blade asdescribed hereinabove with respect to FIGS. 22-24 may be combined with aconductive polymer clamp arm pad as described hereinbelow with respectto FIGS. 25-39.

Configurations of end-effectors comprising a deflectable/cantileverelectrode described hereinabove with respect to FIGS. 1-12 incombination with a biased electrode as described hereinabove withrespect to FIGS. 13-18 may be combined with a conductive polymer clamparm pad as described hereinbelow with respect to FIGS. 25-39.

Configurations of end-effectors comprising a deflectable/cantileverelectrode described hereinabove with respect to FIGS. 1-12 incombination with a biased electrode as described hereinabove withrespect to FIGS. 13-18 may be combined with a flexible electrodedisposed above a lattice cushion and a plurality of hard spacers to seta gap between the flexible electrode and the ultrasonic blade asdescribed hereinabove with respect to FIGS. 22-24 may be combined with aconductive polymer clamp arm pad as described hereinbelow with respectto FIGS. 25-39.

In various aspects, the present disclosure provides a combinationultrasonic/bipolar RF energy surgical device comprising an ultrasonicpad with partially or fully electrically conductive portions such thatthe pad behaves as both the blade support/wear pad and the bipolar RFelectrode. In one aspect, the present disclosure provides a partiallyconductive clamp arm pad to enable electrode wear and minimize shortcircuiting in a combination bipolar RF and ultrasonic energy devicewhere the clamp arm pad has conductive and non-conductive portionsallowing it to act as one of the RF electrodes while also acting as awearable support structure for the ultrasonic blade. In another aspect,the present disclosure provides conductive portions around the perimeterof the clamp arm pad and not positioned directly on the side that isopposite the ultrasonic blade contact area. In another aspect, a portionof the conductive clamp arm pad is degradable or wearable preventingcontact from the ultrasonic blade from interrupting the conductivity ofthe remaining portions of the conductive clamp arm pad.

In one aspect, the present disclosure provides an end-effector for acombination ultrasonic/bipolar RF energy surgical device comprising aconductive polymer ultrasonic clamp arm pad. In one aspect, theend-effector comprises a clamp arm pad doped with tin oxide. FIG. 25 isa section view of a conductive polymer clamp arm pad 2440, according toat least one aspect of the present disclosure. The conductive polymerclamp arm pad 2440 comprises tin oxide 2442 (SnO₂) embedded in a polymermaterial 2444, such as Teflon (PTFE), to make the clamp arm pad 2440electrically conductive. The doping may be achieved using a cold sprayprocess. Once doped, the conductive polymer clamp arm pad 2440 canachieve traditional ultrasonic tissue clamp arm pad functions such as,for example, contacting the ultrasonic blade, absorbing heat from theultrasonic blade, and assisting in tissue grasping and clamping. The tinoxide doped clamp arm pad 2440 functions as one of the two electrodes orpoles of the bipolar RF circuit to deliver RF energy to tissue graspedbetween the ultrasonic blade and the clamp arm pad 2440. The tin oxidedoped clamp arm pad 2440 is biocompatible, electrically conductive,thermally conductive, enables a large portion of the clamp arm pad 2440to be used to improve wear resistance of the clamp arm pad 2440, and iswhite in color. The electrode is adapted and configured for use with acombination ultrasonic/bipolar RF energy surgical device and isdeflectable under load, where the electrode is one pole of the bipolarRF circuit and the ultrasonic blade is the opposite pole of the bipolarRF circuit.

In one aspect, the present disclosure provides a conductive polymerultrasonic clamp arm pad as an electrode replacement. To improve thelife of the ultrasonic clamp arm pad and improve the RF tissue effects,the present disclosure provides an electrode that is improved, easier tomake, and less costly to make. In one aspect, the present disclosureprovides a clamp arm pad comprising hard polyimide polymer layers andelectrically conductive layers to allow the clamp arm pad to achievetraditional functions as well as carry bipolar electricity to eliminatethe need for a separate electrode in the clamp arm of a combined energyend-effector. In this manner, the clamp jaw can be me manufactured in amanner similar to the ultrasonic-only clamp jaw with the new clamp armpad material swapped for the traditional ultrasonic-only clamp arm pad.The electrode is adapted and configured for use with a combinationultrasonic/bipolar RF energy surgical device and is deflectable underload, where the electrode is one pole of the bipolar RF circuit and theultrasonic blade is the opposite pole of the bipolar RF circuit.

Benefits include improved ultrasonic performance, including clamp armpad wear, similar to current ultrasonic-only instruments because thereare no electrode gaps between elements “squares” of polymer. The cost ofthe improved clamp jaw will be similar to current ultrasonic-only clampjaws because of the need for a separate electrode component iseliminated and provides multiple small polymer square elements. Inaddition, the manufacturing steps needed to make the clamp jaw are thesame as the manufacturing steps required for making currentultrasonic-only clamp jaws. Manufacturing the improved clamp jawrequires only the substitution of the clamp arm pad and does require theproduction of an additional electrode component to add to the clamp jawand eliminates assembly steps.

FIG. 26 is a perspective view of a clamp arm pad 2450 configured toreplace a conventional electrode, according to at least one aspect ofthe present disclosure. The clamp arm pad 2450 comprises electricallynon-conductive layers 2452 and electrically conductive layers 2454 in asandwich-like configuration. This configuration eliminates the need fora spring loaded electrode plate. The electrically non-conductive layers2452 can be made of polymer, polyimide, Teflon (PTFE) and similarelectrically non-conductive materials. The conductive layers 2454 may bemade of thin electrically conductive polymer, metal foil, or carbonloaded material. The clamp arm pad 2450 may be manufactured such thatthe majority of the material contacting the ultrasonic blade are theelectrically non-conductive layers 2452. In one aspect, 75% of thematerial contacting the ultrasonic blade is electrically non-conductivematerial such as PTFE. In another aspect, 85% of the material contactingthe ultrasonic blade is electrically non-conductive material such asPTFE. In another aspect, 95% of the material contacting the ultrasonicblade is electrically non-conductive material such as PTFE.Additionally, as the clamp arm pad 2450 wears, the electricallyconductive layers 2452 will still have available surface area to conductRF electricity through the tissue and return electrode (e.g., ultrasonicblade).

FIG. 27 illustrates a clamp arm 2460 comprising the clamp arm pad 2450described in FIG. 26, according to at least one aspect of the presentdisclosure. In the illustrated clamp arm 2460, the non-conductive layers2452 have a large surface area compared to the conductive layers 2454,which appear as thin layers or foils.

FIG. 28 illustrates clamp arm pads configured as described in FIGS.26-27, according to at least one aspect of the present disclosure. Thefirst clamp arm pad 2470 is new and comprises teeth 2472 formedintegrally therewith. The second clamp arm pad 2476 is new and withoutteeth. The third clamp arm pad 2478 worn and may be representative ofeither the first clamp arm pad 2470 or the second clamp arm pad 2476.

In one aspect, the present disclosure provides a composite clamp arm padfor a combination ultrasonic/bipolar RF energy surgical device. FIG. 29is a section view of a clamp arm 2480 comprising a composite clamp armpad 2482 in contact with tissue 2484, according to at least one aspectof the present disclosure. The end-effector 2480 comprises an upperclamp jaw 2486 and an adhesive 2488 to fixedly attach the compositeclamp arm pad 2482 to the upper clamp jaw 2486. The composite clamp armpad 2482 comprises thin electrically non-conductive layers 2490 (e.g.,PTFE) and thin electrically conductive layers 2492 (e.g., thin stainlesssteel foils). The electrically conductive layers 2492 form the electrodeportion of the composite clamp arm pad 2482. The electrically conductivelayers 2492 (e.g., thin stainless steel foils) deform as theelectrically non-conductive layers 2490 (e.g., PTFE) wear-away. Thethickness of the electrically conductive layers 2492 enables theelectrode portion of the composite clamp arm pad 2482 to deform as theelectrically non-conductive layers 2490 wear-away. Advantageously, theelectrically conductive layers 2492 conduct some of the heat away fromthe electrically non-conductive layers 2490 to keep the composite clamparm pad 2482 cooler. As described above, the composite clamp arm pad2482 is fixed to the upper clamp jaw 2486 by an adhesive 2488. Theadhesive 2488 may be filled with carbon to make it electricallyconductive and connect the electrode portions of the composite clamp armpad 2482 to the upper clamp jaw 2486. The electrode is adapted andconfigured for use with a combination ultrasonic/bipolar RF energysurgical device and is deflectable under load, where the electrode isone pole of the bipolar RF circuit and the ultrasonic blade is theopposite pole of the bipolar RF circuit.

In one aspect, the clamp arm pad comprises cooperative conductive andinsulative portions._In one aspect, the present disclosure provides acombination ultrasonic/bipolar RF energy surgical device where the clamparm pad has conductive and non-conductive portions allowing it to act asone of the RF electrodes while also acting as the wearable supportstructure for the ultrasonic blade. In another aspect, the conductiveportions of the clamp arm pad are disposed around the perimeter of thepad and are not positioned directly on the side that is opposite theultrasonic blade contact area. In another aspect, the conductive portionof the clamp arm pad is degradable or wearable to prevent contact withthe ultrasonic blade from interrupting the conductivity of the remainingconductive portions of the clamp arm pad.

In one aspect, the present disclosure provides a clamp arm pad for usewith combination ultrasonic/bipolar RF energy devices where portions ofthe clamp arm pad include electrically conductive material and otherportions include electrically non-conductive material. The electrode isadapted and configured for use with a combination ultrasonic/RF energydevice and is deflectable under load, where the electrode is one pole ofthe bipolar RF circuit and the ultrasonic blade is the opposite pole ofthe bipolar RF circuit.

In various aspects, the clamp arm pad may be manufactured using avariety of techniques. One technique comprises a two shot process ofmolding conductive and non-conductive materials in the same compressionmold. This process effectively creates a single clamp arm pad withportions that can act as a bipolar RF electrode and others that will actas electrical insulators. Another technique comprises a super sonic coldspray embedding of metallic elements into a polymeric (e.g., Teflon,PTFE) pad or matrix. Another technique comprises 3D printing of multiplematerials (e.g., Teflon, PTFE, and doped conductive polymer),printing/transfer printing conductive or functional inks onto clamp armpad. Another technique comprises metals and conductive materials (e.g.,graphite/carbon) may be applied to the clamp arm pad using chemicalvapor deposition, physical vapor deposition, sputter deposition, vacuumdeposition, vacuum metalizing, or thermal spray. Another techniquecomprises conductive/loaded clamp arm pad electrodes provide continuitythrough the pad with micro randomly oriented and positioned particles ormacro oriented structures (e.g., fabric, woven, long constrained fibers.Another technique comprises making the surface of the clamp arm padconductive, providing wear-through electrodes, 3D printing, thermalspraying, cold spraying, coatings/paints/epoxies, sheet/foil/wire/filmwrapping or laminating, vacuum metalizing, printing/transferring, amongother techniques. In another technique, polymer electrodes filled withconductive material.

In one aspect, the end-effector clamp arm comprises a fixed polymerelectrode. FIG. 30 illustrates a clamp arm 2500 comprising a clamp jaw2502 to support a carrier 2504 or stamping attached to the clamp jaw2502 and a clamp arm pad 2506, according to at least one aspect of thepresent disclosure. The clamp arm pad 2506 comprises an electricallyconductive pad 2508 and an electrically non-conductive pad 2510. Theelectrically conductive pad 2508 is made of an electrically conductivepolymer and acts as one of the electrodes of the bipolar RF circuit. Theclamp jaw 2502 and the carrier 2504 may be made of stainless steel andattached using any suitable fastening technique such as welding, laserwelding, brazing, soldering, pressing, among other fastening techniques,for example. The electrically conductive pad 2508 may comprise a polymersuch as, for example, silicone, fluorosilicone, PTFE, and similarmaterials. The electrically conductive pad 2508 is overmolded onto thecarrier 2504 using PTFE, silicone, fluorosilicone filled with silverparticles, silver over aluminum, silver over copper, copper, nickel,graphite, carbon (amorphous, chopped fiber), gold, platinum, stainlesssteel, iron, or zinc, or combinations thereof.

FIG. 31 is a section view taken at section 31-31 in FIG. 30 and FIG. 32is a section view taken at section 32-32 in FIG. 30. The sections views31-31 and 32-32 show the clamp arm 2500 comprising the clamp jaw 2502,the support carrier 2504, the electrically conductive pad 2508, and theelectrically non-conductive pad 2510.

FIG. 33 is a section view of an alternative implementation of a clamparm 2520 comprising a clamp jaw 2522, an electrically conductive pad2524, and an electrically non-conductive pad 2526, according to at leastone aspect of the present disclosure. The electrically conductive pad2524 is made of an electrically conductive polymer and acts as one ofthe electrodes in the bipolar RF circuit.

FIG. 34 is a section view of an alternative implementation of a clamparm 2530 comprising a clamp jaw 2532, a carrier 2534 or stamping weldedto the clamp jaw 2532, an electrically conductive pad 2536, and anelectrically non-conductive pad 2538, according to at least one aspectof the present disclosure. The electrically conductive pad 2536 is madeof an electrically conductive polymer and acts as one of the electrodesin the bipolar RF circuit. The electrically conductive pad 2536 isovermolded over the carrier 2534 or stamping.

In one aspect, the end-effector clamp arm comprises a film over metalinsert molded electrode assembly. In one aspect, a film may be providedover a metal (e.g., stainless steel) insert molded electrode assembly. Afilm over metal such as stainless steel can be insert molded to form anelectrode assembly. The film on the insert molded electrode may beetched to form micro-holes, slots, honeycomb, among other patterns, toenable conduction of RF energy as well as to cut the periphery of thecomponent. The film may be formed onto or bond onto a stainless steelelectrode using IML/FIM (In-Mold Labeling/Film Insert Molding) processesdescribed hereinbelow. The charged film electrode may be placed into apolymer injection mold tool to mold a polymer to the back of theelectrode and film. The electrode is adapted and configured for use witha combination ultrasonic/bipolar RF energy surgical device and isdeflectable under load, where the electrode is one pole of the bipolarRF circuit and the ultrasonic blade is the opposite pole of the bipolarRF circuit.

FIG. 35 illustrates insert molded electrodes 2540, according to at leastone aspect of the present disclosure. The insert molded electrode 2540comprises an electrically conductive element 2546, a molded polymer pad2548, and a film 2542 coating. Features 2550 such as micro-holes, slots,honeycomb, or similar features, are formed in the film 2542 to allow thepassage of RF energy. Retention features 2552 also are formed on thefilm 2542. The side walls 2558 of the film 2542 extend below the bottomof the polymer pad 2548 may be folded around the bottom of the polymerpad 2548 and over molded with retention posts. The retention features2552 are molded into the holes 2554 defined by the film 2542. Althoughthe two insert molded electrodes 2540 are shown with a gap between them,in actuality, the two insert molded electrodes 2540 are fit line-to-line2556 via mold pressure.

The conductive element 2546 may be made of an electrically conductivemetal such as stainless steel or similar conductive material. Theconductive element 2546 can be about 0.010″ thick and may be selectedwithin a range of thicknesses of 0.005″ to 0.015″ and can be formed bytamping or machining. The film 2544 can be about 0.001″ to 0.002″ thickand may be made of polyimide, polyester, or similar materials.Alternatively to mechanical retention, such as posts, the film 2544 canbe directly bonded to the conductive element 2546. One example includesDuPont Pyralux HXC Kapton film with epoxy adhesive backing having athickness of 0.002″.

Advantageously, the non-stick surface prevents tissue from sticking tothe insert molded electrode 2540. The non-stick surface eliminates shortcircuiting of opposing electrodes by setting a gap within the range of0.002″ to 0.004″ along the entire length of the insert molded electrode2540. The non-stick surface minimizes lateral spread of RF energy due tocoverage of side walls 2558 of the insert molded electrode 2540. Also,the insert molded electrode 2540 exhibits structural soundness andprovides an easier more robust electrical connection than a multi-layerflexible circuit.

In one aspect, the end-effector comprises a conductive clamp arm and padconstructs for combination ultrasonic/bipolar RF energy surgicaldevices. In one aspect, the present disclosure provides a clamp armassembly comprising a conductive or selectively conductive thin film,foil, or laminate that is applied to, around or on the clamp armassembly to serve as a durable “pole” in a combinationultrasonic/bipolar RF energy surgical device. Further, an algorithm,software, or logic is provided to manage conditions of electrical shortcircuiting. The electrode is adapted and configured for use with acombination ultrasonic/bipolar RF energy surgical device and isdeflectable under load, where the electrode is one pole of the bipolarRF circuit and the ultrasonic blade is the opposite pole of the bipolarRF circuit.

FIG. 36 illustrates an end-effector 2560 comprising an ultrasonic blade2562, a clamp arm 2564, and a clamp arm pad 2566 comprising anelectrically conductive film 2568, according to at least one aspect ofthe present disclosure.

FIG. 37 illustrates the clamp arm 2564 shown in FIG. 36. The clamp arm2564 comprising a clamp jaw 2570 to support the clamp arm pad 2566. Athin electrically conductive film 2568 is disposed over the clamp armpad 2566 to form an electrode of one of the poles of the bipolar RFcircuit.

FIG. 38 is a section view of the clamp arm 2564 taken along section38-38 in FIG. 37. The clamp jaw 2570 can be made of metal such asstainless steel. The clamp arm pad 2566 can be made of an electricallynon-conductive complaint material such as PTFE, silicone, hightemperature polymer, or similar materials. The electrically conductivefilm 2568 or foil can be made of an electrically conductive materialsuch as titanium, silver, gold, aluminum, zinc, and any alloys thereofincluding stainless steel.

FIG. 39 illustrates a clamp arm 2580 comprising a partially electricallyconductive clamp arm pad 2582, according to at least one aspect of theresent disclosure. An electrically conductive foil 2584 covers a portionof an electrically non-conductive pad 2586. The electricallynon-conductive pad 2588 at the proximal end 2590 sets a gap between theclamp arm pad 2582 and the ultrasonic blade.

Elements of the electrically conductive film 2568, foil, or laminate mayinclude, for example, a single layer of thin conductive material such asmetals (titanium, silver, gold, zinc, aluminum, magnesium, iron, etc.and their alloys or stainless steels), plated metals (nickel and thengold over copper, for example) or polymers filled heavily withconductive materials such as metal powder, or filings. Preferably, it isa biocompatible metal foil such as titanium, silver, gold, zinc, orstainless steel selected from a thickness within the range of 0.001″ to0.008″ (0.025 mm-0.20 mm).

The film 2568, foil, or laminate may include a thin polymer coating,film or layer covering the thin conductive material described above.This coating, film or layer is highly resistive, that is, it is not aneffective conductor of bipolar RF energy to adjacent tissue. The coatingmay be perforated to allow for energy delivery from the electrode totissue.

The conductive material may be perforated or contain holes or windowsthrough the full thickness of the conductive material to minimize thethermal capacitance of this layer (testing has shown that long and/orthick foils result in longer transection times due to thermal energybeing removed from the treatment sight. These perforations, holes orwindows also may allow for retention of the foil to other parts orlayers. These perforations, holes or windows may be patterned across theentire foil sheet or may be localized at the treatment site or away fromthe treatment site such as, for example, on the sides of the clamp armonly.

If present, the thin polymer coating, film or layer may be perforated orcontain full thickness holes or windows such that the conductive film,foil or laminate is in direct communication with tissue for delivery ofbipolar radiofrequency energy to the tissue. For coatings, these holesor windows may be formed by selective coating or coating removal.

Ideally, the conductive film 2568, foil, or laminate is in directcontact with the clamp arm structure that is typically fabricated fromstainless steel. The resulting conductive path then allows forsimplicity of construction in that the path is formed by necessarystructural component, namely a support tube or actuator that connectsdirectly to the clamp arm and then the conductive film, foil orlaminate.

In one aspect, the conductive film 2568, foil, or laminate is backed bya relatively soft, high temperature, low wear polymer or elastomer padmade from materials such as PTFE, silicone, polyimide, high temperaturethermoplastics, among other materials. The compliance of this relativelysoft pad allows for a wide range of component tolerances to obtain azero or near zero gap between the jaw and the ultrasonic blade along itsfull tissue effecting length when the jaw is fully closed, thus allowingtissue to be sealed and cut along this length. The compliance alsoeliminates or greatly dampens any audible vibration of the conductivelayer that may occur when the ultrasonic blade is closed against theconductive layer.

The conductive film 2568, foil, or laminate may include a rigid tosemi-rigid polymer on its backside/back surface (that is the surfaceaway from the tissue and toward the clamp arm). This part is made frominjection moldable polymers or polymer alloys and adhered to the film,foil or laminate by way of Film Insert Molding (FIM) or In-Mold Labeling(IML).

In testing, thin stainless steel, copper, or aluminum foils are quiet inoperation (no “screeching” or emitting of obtuse squeals). The thinstainless steel, copper, or aluminum foils provide a robust surfaceagainst which the ultrasonic blade can act. Robust enough that materialssuch as silicone rubber that would otherwise tear and serve as a poorpad material are usable and do not easily tear or split.

The proximal portion of the jaw clamping surface may not include theconductive film, foil or laminate because this area of the jaw contactsthe blade first and will be more likely result in shunting ofpower/shorting in this area.

In one aspect, the present disclosure provides a short circuitmitigation algorithm for activating an output including bipolar RFenergy.

A short alert is not given to the user if it occurs after the energydelivered for the activation exceeds a threshold amount (therebyindicating that the tissue thinned but has likely received an adequatedose of bipolar RF energy for the sealing, coagulation of tissue), or anactivation time threshold has been exceeded (again, thereby indicatingthat the tissue has thinned but has likely received and adequate dose),or both energy and activation time thresholds have been exceeded.

A process of making a film over stainless steel insert molded electrodeassembly comprises etching the film and forming apertures (micro-holes,slots, or honeycomb) for passing RF energy; cutting periphery of theelectrode component; forming a film onto/bond onto stainless steelelectrode if needed; placing the charged film and electrode into apolymer injection mold tool; molding the polymer to the back of theelectrode and film.

In various aspects, the present disclosure provides combinationultrasonic/bipolar RF energy surgical devices and systems. Various formsare directed to user interfaces for surgical instruments with ultrasonicand/or electrosurgical (RF) end-effectors configured for effectingtissue treating, dissecting, cutting, and/or coagulation during surgicalprocedures. In one form, a user interface is provided for a combinedultrasonic and electrosurgical instrument that may be configured for usein open surgical procedures, but has applications in other types ofsurgery, such as minimally invasive laparoscopic procedures, forexample, non-invasive endoscopic procedures, either in hand held or androbotic-assisted procedures. Versatility is achieved by selectiveapplication of multiple energy modalities simultaneously, independently,sequentially, or combinations thereof. For example, versatility may beachieved by selective use of ultrasonic and electrosurgical energy(e.g., monopolar or bipolar RF energy) either simultaneously,independently, sequentially, or combinations thereof.

In one aspect, the present disclosure provides a user interface for anapparatus comprising an ultrasonic blade and clamp arm with adeflectable RF electrode such that the ultrasonic blade and deflectableRF electrode cooperate to effect sealing, cutting, and clamping oftissue by cooperation of a clamping mechanism of the apparatuscomprising the RF electrode with an associated ultrasonic blade. Theclamping mechanism includes a pivotal clamp arm which cooperates withthe ultrasonic blade for gripping tissue therebetween. The clamp arm ispreferably provided with a clamp tissue pad (also known as “clamp armpad”) having a plurality of axially spaced gripping teeth, segments,elements, or individual units which cooperate with the ultrasonic bladeof the end-effector to achieve the desired sealing and cutting effectson tissue, while facilitating grasping and gripping of tissue duringsurgical procedures.

In one aspect, the end-effectors described herein comprise an electrode.In other aspects, the end-effectors described herein comprisealternatives to the electrode to provide a compliant coupling of RFenergy to tissue, accommodate pad wear/thinning, minimize generation ofexcess heat (low coefficient of friction, pressure), minimize generationof sparks, minimize interruptions due to electrical shorting, orcombinations thereof. The electrode is fixed to the clamp jaw at theproximal end and is free to deflect at the distal end. Accordingly,throughout this disclosure the electrode may be referred to as acantilever beam electrode or as a deflectable electrode.

In other aspects, the end-effectors described herein comprise a clamparm mechanism configured to high pressure between a pad and anultrasonic blade to grasp and seal tissue, maximize probability that theclamp arm electrode contacts tissue in limiting or difficult scenarios,such as, for example, thin tissue, tissue under lateral tension, tissuetenting/vertical tension especially tenting tissue away from clamp arm.

In other aspects, the end-effectors described herein are configured tobalance match of surface area/current densities between electrodes,balance and minimize thermal conduction from tissue interface, such as,for example, impacts lesion formation and symmetry, cycle time, residualthermal energy. In other aspects, the end-effectors described herein areconfigured to minimize sticking, tissue adherence (minimize anchorpoints) and may comprise small polyimide pads.

In various aspects, the present disclosure provides a surgical deviceconfigured to deliver at least two energy types (e.g., ultrasonic,monopolar RF, bipolar RF, microwave, or irreversible electroporation[IRE]) to tissue. The surgical device includes a first activation buttonswitch for activating energy, a second button switch for selecting anenergy mode for the activation button switch. The second button switchis connected to a circuit that uses at least one input parameter todefine the energy mode. The input parameter can be modified remotelythrough connection to a generator or through a software update.

In one aspect, at least one of the energy modes is a simultaneous blendof RF and ultrasonic energy, and the input parameter represents a dutycycle of the RF and ultrasonic energy.

In one aspect, the second button switch is configurable to select from alist of predefined modes and the number of modes in the list is definedby a second input parameter defined by a user.

In one aspect, the input parameter is either duty cycle, voltage,frequency, pulse width, or current.

In one aspect, the device also includes a visual indicator of theselected energy mode within the portion of device in the surgical field

In one aspect, the second button switch is a separate control from theend effector closure trigger.

In one aspect, the second button switch is configured to be activatedsecond stage of the closure trigger. The first stage of the closuretrigger in the closing direction is to actuate the end effector.

In one aspect, at least one of the energy modes is selected fromultrasonic, RF bipolar, RF monopolar, microwave, or IRE.

In one aspect, at least one of the energy modes is selected fromultrasonic, RF bipolar, RF monopolar, microwave, or IRE and isconfigured to be applied in a predefined duty cycle or pulsed algorithm.

In one aspect, at least one of the energy modes is selected from asequential application of two or more of the following types of energy:ultrasonic, RF bipolar, RF monopolar, microwave, or IRE.

In one aspect, at least one of the energy modes is a simultaneous blendof two or more of the following types of energy: ultrasonic, RF bipolar,RF monopolar, microwave, and IRE.

In one aspect, at least one of the energy modes is a simultaneous blendof two or more of the following types of energy: ultrasonic, RF bipolar,RF monopolar, microwave, and IRE followed sequentially by one or more ofthe aforementioned energies.

In one aspect, at least one of the energy modes is one off the followingtypes of energy: Ultrasonic, RF bipolar, RF monopolar, microwave, andIRE followed sequentially by a simultaneous blend of two or more of theaforementioned energies.

In one aspect, at least one of the energy modes is procedure or tissuespecific predefined algorithm.

In one aspect, at least one of the energy modes is compiled from learnedsurgical behaviors or activities.

In one aspect, the input parameter is at least one of: energy type, dutycycle, voltage, frequency, pulse width, current, impedance limit,activation time, or blend of energy.

In one aspect, the second button switch is configurable to select from alist of predefined modes and the number of modes in the list is eitherpredefined or defined by a second input parameter defined by a user.

In one aspect, the aforementioned energy modes are made available to theuser through software updates to the generator.

In one aspect, the aforementioned energy modes are made available to theuser through software updates to the device.

In one aspect, the preferred selections by the user are made availableto multiple generators through either networking, the cloud, or manualtransfer.

In one aspect, the device also includes a visual indicator of theselected energy mode within the portion of device in the surgical field.

As used herein a button switch can be a manually, mechanically, orelectrically operated electromechanical device with one or more sets ofelectrical contacts, which are connected to external circuits. Each setof electrical contacts can be in one of two states: either “closed”meaning the contacts are touching and electricity can flow between them,or “open”, meaning the contacts are separated and the switch iselectrically non-conducting. The mechanism actuating the transitionbetween these two states (open or closed) can be either an “alternateaction” (flip the switch for continuous “on” or “off”) or “momentary”(push for “on” and release for “off”) type.

In one aspect, the present disclosure provides a combinationultrasonic/bipolar RF energy surgical device comprising on device modeselection and visual feedback. As surgical devices evolve and becomemore capable, the number of specialized modes in which they can beoperated increases. Adding extra button switches on a device toaccommodate these new additional modes would complicate the userinterface and make the device more difficult to use. Accordingly, thepresent disclosure provides techniques for assigning different modes toa single physical button switch, which enables a wider selection ofmodes without adding complexity to the housing design (e.g., adding moreand more button switches). In one aspect, the housing is in the form ofa handle or pistol grip.

As more specialized modes become available, there is a need to providemultiple modes to a surgeon using the surgical device without creating acomplex user interface. Surgeons want to be able to control the modeselection from the sterile field rather than relying on a circulatingnurse at the generator. Surgeon want real time feedback so they areconfident they know which mode is selected.

FIG. 40 illustrates a surgical device 100 comprising a mode selectionbutton switch 130 on the device 100, according to at least one aspect ofthe present disclosure. The surgical device 100 comprises a housing 102defining a handle 104 in the form of a pistol grip. The housing 102comprises a trigger 106 which when squeezed is received into theinternal space defined by the handle 104. The trigger 106 is used tooperate a clamp arm 111 portion of an end-effector 110. A clamp jaw 112is pivotally movable about pivot point 114. The housing 102 is coupledto the end-effector 110 through a shaft 108, which is rotatable by aknob 122.

The end-effector 110 comprises a clamp arm 111 and an ultrasonic blade116. The clamp arm 111 comprises a clamp jaw 112, an electrode 118, anda clamp arm pad 120. In one aspect, the clamp arm pad 120 is made of anon-stick lubricious material such as PTFE or similar syntheticfluoropolymers of tetrafluoroethylene. PTFE is a hydrophobic,non-wetting, high density and resistant to high temperatures, andversatile material and non-stick properties. The clamp arm pad 120 iselectrically non-conductive. In contrast, the electrode 118 is made ofan electrically conductive material to deliver electrical energy such asmonopolar RF, bipolar RF, microwave, or irreversible electroporation(IRE), for example. The electrode 118 may comprises gap setting padsmade of a polyimide material, and in one aspect, is made of a durablehigh-performance polyimide-based plastic known under the tradenameVESPEL and manufactured by DuPont or other suitable polyimide, polyimidepolymer alloy, or PET (Polyethylene Terephthalate), PEEK (PolyetherEther Ketone), PEKK (Poly Ether Ketone Ketone) polymer alloy, forexample. Unless otherwise noted hereinbelow, the clamp arm pads and gappads described hereinbelow are made of the materials described in thisparagraph.

The electrode 118 and the ultrasonic blade 116 are coupled to thegenerator 133. The generator 133 is configured to drive RF, microwave,or IRE energy to the electrode 118. The generator 133 also is configuredto drive an ultrasonic transducer acoustically coupled to the ultrasonicblade 116. In certain implementations, the electrode 118 is one pole ofan electrical circuit and the ultrasonic blade 116 is the opposite poleof the electrical circuit. The housing 102 includes a switch 124 toactivate the ultrasonic blade 116. The circuit may be contained in thehousing 102 or may reside in the generator 133. The surgical device 100is coupled to the generator 133 via a cable 131. The cable 131 conductssignals for the electrosurgical functions and the ultrasonic transducer.

In various aspects, the surgical device 100 is configured to deliver atleast two energy types (e.g., ultrasonic, monopolar RF, bipolar RF,microwave, or irreversible electroporation [IRE]) to tissue located inthe end-effector 110 between the clamp arm 111 and the ultrasonic blade116. The housing 102 of the surgical device 100 includes a firstactivation button switch 126 for activating energy and a second “mode”button switch 130 for selecting an energy mode for the activation buttonswitch. The second button switch 130 is connected to a circuit that usesat least one input parameter to define the energy mode. The inputparameter can be modified remotely through connection to a generator orthrough a software update. The energy mode is displayed on a userinterface 128.

In one aspect, the surgical instrument 100 provides mode switchingthrough the on device directional selector “mode” button switch 130. Theuser can press the mode button switch 130 to toggle through differentmodes and the colored light on the user interface 128 indicates theselected mode.

According to various aspects of the present disclosure, different modesof operation can be assigned to the surgical device by pressing the“mode” button switch 130, where each time the mode button switch 130 ispressed, or pushed and held, the surgical device 100 toggles through theavailable modes, which are displayed on the user interface 128. Once amode is selected, the generator 133 will provide the appropriategenerator tone and the surgical device 100 will have a lighted indicatoron the user interface 128 to indicate which mode was selected.

In the example illustrated in FIG. 40, the “mode” selection buttonswitch 130 is placed symmetrically on both sides of the housing 102.This enables both a right and left handed surgeon to select/togglethrough modes without using a second hand. In this aspect, the “mode”selection button switch 130 can toggle in many different directions,which enables the surgeon to select from a list of options and navigatemore complex selections remotely from the sterile field without havingto ask a circulator to make adjustments at the generator 133. Thelighted indicator on the user interface 128 of the surgical device 100,in addition to generator 133 tones, gives the surgeon feedback on whichmode is selected.

FIGS. 41A-41C illustrate three options for selecting the variousoperating modes of the surgical device 100, according to at least oneaspect of the present disclosure. In addition to the colored light userinterface 128 on the housing 102 of the surgical device 100, feedbackfor mode selection is audible and/or visible through the generator 133interface where the generator 133 announces the selected mode verballyand/or shows a description of the selected mode on a screen of thegenerator 133.

FIG. 41A shows a first mode selection option 132A where the buttonswitch 130 can be pressed forward 136 or backward 134 to cycle thesurgical instrument 100 through the various modes.

FIG. 41B shows a second mode selection option 132B where the buttonswitch 130 is pressed up 140 or down 138 to cycle the surgicalinstrument 100 through the various modes.

FIG. 41C shows a third mode selection option 132C where the buttonswitch 130 is pressed forward 136, backward 134, up 149, or down 138 tocycle the surgical instrument 100 through the various modes.

FIG. 42 illustrates a surgical device 150 comprising a mode selectionbutton switch 180 on the back of the device 150, according to at leastone aspect of the present disclosure. The surgical device 150 comprisesa housing 152 defining a handle 154 in the form of a pistol grip. Thehousing 152 comprises a trigger 156 which when squeezed is received intothe internal space defined by the handle 154. The trigger 156 is used tooperate a clamp arm 161 portion of an end-effector 160. A clamp jaw 162is pivotally movable about pivot point 164. The housing 152 is coupledto the end-effector 160 through a shaft 158, which is rotatable by aknob 172.

The end-effector 160 comprises a clamp arm 161 and an ultrasonic blade166. The clamp arm 161 comprises a clamp jaw 162, an electrode 168, anda clamp arm pad 170. In one aspect, the clamp arm pad 170 is made of anon-stick lubricious material such as PTFE or similar syntheticfluoropolymers of tetrafluoroethylene. PTFE is a hydrophobic,non-wetting, high density and resistant to high temperatures, andversatile material and non-stick properties. The clamp arm pad 170 iselectrically non-conductive. In contrast, the electrode 168 is made ofan electrically conductive material to deliver electrical energy such asmonopolar RF, bipolar RF, microwave, or irreversible electroporation(IRE), for example. The electrode 168 may comprises gap setting padsmade of a polyimide material, and in one aspect, is made of a durablehigh-performance polyimide-based plastic known under the tradenameVESPEL and manufactured by DuPont or other suitable polyimide, polyimidepolymer alloy, or PET (Polyethylene Terephthalate), PEEK (PolyetherEther Ketone), PEKK (Poly Ether Ketone Ketone) polymer alloy, forexample. Unless otherwise noted hereinbelow, the clamp arm pads and gappads described hereinbelow are made of the materials described in thisparagraph.

The electrode 168 and the ultrasonic blade 166 are coupled to thegenerator 133. The generator 133 is configured to drive RF, microwave,or IRE energy to the electrode 168. The generator 133 also is configuredto drive an ultrasonic transducer acoustically coupled to the ultrasonicblade 166. In certain implementations, the electrode 168 is one pole ofan electrical circuit and the ultrasonic blade 166 is the opposite poleof the electrical circuit. The housing 152 includes a switch 174 toactivate the ultrasonic blade 166. The circuit may be contained in thehousing 152 or may reside in the generator 133. The surgical device 150is coupled to the generator 133 via a cable 181. The cable 181 conductssignals for the electrosurgical functions and the ultrasonic transducer.

In various aspects, the surgical device 100 is configured to deliver atleast two energy types (e.g., ultrasonic, monopolar RF, bipolar RF,microwave, or irreversible electroporation [IRE]) to tissue located inthe end-effector 110 between the clamp arm 111 and the ultrasonic blade116. The housing 102 of the surgical device 100 includes a firstactivation button switch 126 for activating energy and a second “mode”button switch 130 for selecting an energy mode for the activation buttonswitch. The second button switch 130 is connected to a circuit that usesat least one input parameter to define the energy mode. The inputparameter can be modified remotely through connection to a generator orthrough a software update. The energy mode is displayed on a userinterface 128.

In one aspect, the surgical instrument 150 provides mode switchingthrough the on device directional selector “mode” button switch 180. Theuser can press the mode button switch 180 to toggle through differentmodes and the colored light on the user interface 178 indicates theselected mode.

According to various aspects of the present disclosure, different modesof operation can be assigned to the surgical device by pressing the“mode” button switch 180, where each time the mode button switch 180 ispressed, or pushed and held, the surgical device 150 toggles through theavailable modes, which are displayed on the user interface 178. Once amode is selected, the generator 133 will provide the appropriategenerator tone and the surgical device 150 will have a lighted indicatoron the user interface 178 to indicate which mode was selected.

In the example illustrated in FIG. 421, the “mode” selection buttonswitch 180 is placed on the back of the surgical device 150. Thelocation of the “mode” selection button switch 180 is out of the reachof the surgeon's hand holding the surgical device 150 so a second handis required to change modes. This is intended to prevent inadvertentactivation. In order to change modes, a surgeon must use her second handto intentionally press the mode button switch 180. The lighted indicatoron the user interface 178 of the surgical device 150, in addition togenerator tones gives the surgeon feedback on which mode is selected.

FIG. 43A shows a first mode selection option where as the mode buttonswitch 180 is pressed to toggled through various modes, colored lightindicates the selected mode on the user interface 178.

FIG. 43B shows a second mode selection option where as the mode buttonswitch 180 is pressed to toggle through various modes a screen 182indicates the selected mode (e.g., LCD, e-ink).

FIG. 43C shows a third mode selection option where as the mode buttonswitch 180 is pressed to toggle through various modes, labelled lights184 indicate the selected mode.

FIG. 43D shows a fourth mode selection option where as a labeled buttonswitch 186 is pressed to select a mode, when a labeled button switch 180is selected, it is illuminated to indicate mode selected

In one aspect, the present disclosure provides a combinationultrasonic/bipolar RF energy surgical device comprising energyactivation with trigger closure. As more functionality is added toadvanced energy surgical devices additional button switches or controlsare added to the surgical devices. The additional button switches orcontrols make these advanced energy surgical devices complicated anddifficult to use. Additionally, when using an advanced energy surgicaldevice to control bleeding, difficult to use user interfaces ordifficult to access capability will cost critical time and attentionduring a surgical procedure.

According to the present disclosure, monopolar RF energy or advancedbipolar RF energy is activated by closing the trigger by squeezing thetrigger past a first closure click to a second activation click andholding closed until energy delivery is ceased by the power source inthe generator. Energy also can be immediately reapplied by slightlyreleasing and re-squeezing the trigger as many times as desired.

FIG. 44 illustrates a surgical device 190 comprising a trigger 196activation mechanism, according to at least one aspect of the presentdisclosure. The surgical device 190 comprises a housing 192 defining ahandle 194 in the form of a pistol grip. The housing 192 comprises atrigger 196 which when squeezed is received into the internal spacedefined by the handle 194. The housing 192 is coupled to an end-effectorthrough a shaft 198, which is rotatable by a knob 202. The surgicaldevice 190 is coupled to a generator 206 via a cable 204. The cable 204conducts signals for the electrosurgical functions and the ultrasonictransducer.

The trigger 196 is configured to operate a clamp arm portion of anend-effector and to trigger electrosurgical energy, thus eliminating theactivation button switch 126, 176 shown in FIGS. 40 and 42. The trigger196 closes to a first audible and tactile click to close the jaws forgrasping tissue and further closes to a second audible and tactile clickto activate electrosurgical energy such as monopolar or bipolar RF.Microwave, or IRE energy. The full sequence is completed by activatingthe front button switch which cuts using ultrasonic energy.

Procedure for operating the surgical device 190: squeeze the trigger 196to a first audible and tactile click; verify targeted tissue in jaws;activate RF energy by further squeezing the trigger 196 to a secondaudible and tactile click until end tone is heard; cut by pressingultrasonic front switch 200 until tissue divides.

Modified procedure for operating the surgical instrument 190 foradditional capability: activate RF energy with the trigger 196 and holdwhile simultaneously activation the front button switch 200 to activatethe ultrasonic transducer, which will result in simultaneous applicationof electrosurgical and ultrasonic energy modalities being delivered tothe tissue at the same time.

In an alternative implementation, the front button switch 200 foractivating ultrasonic energy may be toggled to different speeds via amode selector on the surgical device 190 or on the power sourcegenerator 206.

The surgical instruments 100, 150, 190 and associated algorithmsdescribed above in connection with FIGS. 40-44 comprising theend-effectors described in FIGS. 1-39 may be implemented in thefollowing surgical hub system in conjunction with the followinggenerator and modular energy system, for example.

FIG. 45 illustrates an alternative clamp arm comprising a metal clampjaw, an electrode, a plurality of clamp arm pads, and gap pads,according to at least one aspect of the present disclosure. FIG. 45illustrates an alternative clamp arm 2900 comprising a metal clamp jaw2904, an electrode 2906, a plurality of clamp arm pads 2920 extendthrough holes in the electrode 2906, a gap pad 2930, and a gap pad 2910,according to at least one aspect of the present disclosure. Theelectrode 2906 is attached to the metal jaw 2906 at weld locations 2908.The electrode 2906 wraps around the metal clamp jaw 2904 and electrode2906 can deflect. The gap pad 2910 has a top PI layer 2912 and a bottomelastomer layer 2914 for pressure control that is attached directly tothe metal clamp jaw 2904. The clamp arm pads 2920 are attached directlyto the metal clamp jaw 2904 and are composite pads with a high pressurecenter zone 2922 made of PTFE for reduced heat and an outer zone 2924made of PI for electrode 2906 deflection.

In one aspect, the combination ultrasonic/bipolar RF energy surgicaldevice is configured to operate within a surgical hub system. FIG. 46 isa surgical system 3102 comprising a surgical hub 3106 paired with avisualization system 3108, a robotic system 3110, and an intelligentinstrument 3112, in accordance with at least one aspect of the presentdisclosure. Referring now to FIG. 46, the hub 3106 is depicted incommunication with a visualization system 3108, a robotic system 3110,and a handheld intelligent surgical instrument 3112 configured in asimilar manner to the surgical instruments 100, 150, 190 as described inFIGS. 40-45. The hub 3106 includes a hub display 3135, an imaging module3138, a generator module 3140, a communication module 3130, a processormodule 3132, and a storage array 3134. In certain aspects, asillustrated in FIG. 46, the hub 3106 further includes a smoke evacuationmodule 3126 and/or a suction/irrigation module 3128.

During a surgical procedure, energy application to tissue, for sealingand/or cutting, is generally associated with smoke evacuation, suctionof excess fluid, and/or irrigation of the tissue. Fluid, power, and/ordata lines from different sources are often entangled during thesurgical procedure. Valuable time can be lost addressing this issueduring a surgical procedure. Detangling the lines may necessitatedisconnecting the lines from their respective modules, which may requireresetting the modules. The hub modular enclosure 3136 offers a unifiedenvironment for managing the power, data, and fluid lines, which reducesthe frequency of entanglement between such lines.

Aspects of the present disclosure present a surgical hub for use in asurgical procedure that involves energy application to tissue at asurgical site. The surgical hub includes a hub enclosure and a combogenerator module slidably receivable in a docking station of the hubenclosure. The docking station includes data and power contacts. Thecombo generator module includes two or more of an ultrasonic energygenerator component, a bipolar RF energy generator component, and amonopolar RF energy generator component that are housed in a singleunit. In one aspect, the combo generator module also includes a smokeevacuation component, at least one energy delivery cable for connectingthe combo generator module to a surgical instrument, at least one smokeevacuation component configured to evacuate smoke, fluid, and/orparticulates generated by the application of therapeutic energy to thetissue, and a fluid line extending from the remote surgical site to thesmoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluidline extends from the remote surgical site to a suction and irrigationmodule slidably received in the hub enclosure. In one aspect, the hubenclosure comprises a fluid interface.

Certain surgical procedures may require the application of more than oneenergy type to the tissue. One energy type may be more beneficial forcutting the tissue, while another different energy type may be morebeneficial for sealing the tissue. For example, a bipolar generator canbe used to seal the tissue while an ultrasonic generator can be used tocut the sealed tissue. Aspects of the present disclosure present asolution where a hub modular enclosure 136 is configured to accommodatedifferent generators, and facilitate an interactive communicationtherebetween. One of the advantages of the hub modular enclosure 136 isenabling the quick removal and/or replacement of various modules.

Aspects of the present disclosure present a modular surgical enclosurefor use in a surgical procedure that involves energy application totissue. The modular surgical enclosure includes a first energy-generatormodule, configured to generate a first energy for application to thetissue, and a first docking station comprising a first docking port thatincludes first data and power contacts, wherein the firstenergy-generator module is slidably movable into an electricalengagement with the power and data contacts and wherein the firstenergy-generator module is slidably movable out of the electricalengagement with the first power and data contacts,

Further to the above, the modular surgical enclosure also includes asecond energy-generator module configured to generate a second energy,different than the first energy, for application to the tissue, and asecond docking station comprising a second docking port that includessecond data and power contacts, wherein the second energy-generatormodule is slidably movable into an electrical engagement with the powerand data contacts, and wherein the second energy-generator module isslidably movable out of the electrical engagement with the second powerand data contacts.

In addition, the modular surgical enclosure also includes acommunication bus between the first docking port and the second dockingport, configured to facilitate communication between the firstenergy-generator module and the second energy-generator module.

In one aspect, the present disclosure provides a generator configured todrive the combination ultrasonic/bipolar RF energy surgical device. FIG.47 illustrates an example of a generator 3900, in accordance with atleast one aspect of the present disclosure. As shown in FIG. 47, thegenerator 3900 is one form of a generator configured to couple to asurgical instrument 100, 150, 190 as described in FIGS. 40-45, andfurther configured to execute adaptive ultrasonic and electrosurgicalcontrol algorithms in a surgical data network comprising a modularcommunication hub as shown in FIG. 46. The generator 3900 is configuredto deliver multiple energy modalities to a surgical instrument. Thegenerator 3900 provides RF and ultrasonic signals for delivering energyto a surgical instrument either independently or simultaneously. The RFand ultrasonic signals may be provided alone or in combination and maybe provided simultaneously. As noted above, at least one generatoroutput can deliver multiple energy modalities (e.g., ultrasonic, bipolaror monopolar RF, irreversible and/or reversible electroporation, and/ormicrowave energy, among others) through a single port, and these signalscan be delivered separately or simultaneously to the end effector totreat tissue. The generator 3900 comprises a processor 3902 coupled to awaveform generator 3904. The processor 3902 and waveform generator 3904are configured to generate a variety of signal waveforms based oninformation stored in a memory coupled to the processor 3902, not shownfor clarity of disclosure. The digital information associated with awaveform is provided to the waveform generator 3904 which includes oneor more DAC circuits to convert the digital input into an analog output.The analog output is fed to an amplifier 3906 for signal conditioningand amplification. The conditioned and amplified output of the amplifier3906 is coupled to a power transformer 3908. The signals are coupledacross the power transformer 3908 to the secondary side, which is in thepatient isolation side. A first signal of a first energy modality isprovided to the surgical instrument between the terminals labeledENERGY1 and RETURN. A second signal of a second energy modality iscoupled across a capacitor 3910 and is provided to the surgicalinstrument between the terminals labeled ENERGY2 and RETURN. It will beappreciated that more than two energy modalities may be output and thusthe subscript “n” may be used to designate that up to n ENERGYnterminals may be provided, where n is a positive integer greater than 1.It also will be appreciated that up to “n” return paths RETURNn may beprovided without departing from the scope of the present disclosure.

A first voltage sensing circuit 3912 is coupled across the terminalslabeled ENERGY1 and the RETURN path to measure the output voltagetherebetween. A second voltage sensing circuit 3924 is coupled acrossthe terminals labeled ENERGY2 and the RETURN path to measure the outputvoltage therebetween. A current sensing circuit 3914 is disposed inseries with the RETURN leg of the secondary side of the powertransformer 3908 as shown to measure the output current for eitherenergy modality. If different return paths are provided for each energymodality, then a separate current sensing circuit should be provided ineach return leg. The outputs of the first and second voltage sensingcircuits 3912, 3924 are provided to respective isolation transformers3916, 3922 and the output of the current sensing circuit 3914 isprovided to another isolation transformer 3918. The outputs of theisolation transformers 3916, 3928, 3922 in the on the primary side ofthe power transformer 3908 (non-patient isolated side) are provided to aone or more ADC circuit 3926. The digitized output of the ADC circuit3926 is provided to the processor 3902 for further processing andcomputation. The output voltages and output current feedback informationcan be employed to adjust the output voltage and current provided to thesurgical instrument and to compute output impedance, among otherparameters. Input/output communications between the processor 3902 andpatient isolated circuits is provided through an interface circuit 3920.Sensors also may be in electrical communication with the processor 3902by way of the interface circuit 3920.

In one aspect, the impedance may be determined by the processor 3902 bydividing the output of either the first voltage sensing circuit 3912coupled across the terminals labeled ENERGY1/RETURN or the secondvoltage sensing circuit 3924 coupled across the terminals labeledENERGY2/RETURN by the output of the current sensing circuit 3914disposed in series with the RETURN leg of the secondary side of thepower transformer 3908. The outputs of the first and second voltagesensing circuits 3912, 3924 are provided to separate isolationstransformers 3916, 3922 and the output of the current sensing circuit3914 is provided to another isolation transformer 3916. The digitizedvoltage and current sensing measurements from the ADC circuit 3926 areprovided the processor 3902 for computing impedance. As an example, thefirst energy modality ENERGY1 may be ultrasonic energy and the secondenergy modality ENERGY2 may be RF energy. Nevertheless, in addition toultrasonic and bipolar or monopolar RF energy modalities, other energymodalities include irreversible and/or reversible electroporation and/ormicrowave energy, among others. Also, although the example illustratedin FIG. 47 shows a single return path RETURN may be provided for two ormore energy modalities, in other aspects, multiple return paths RETURNnmay be provided for each energy modality ENERGYn. Thus, as describedherein, the ultrasonic transducer impedance may be measured by dividingthe output of the first voltage sensing circuit 3912 by the currentsensing circuit 3914 and the tissue impedance may be measured bydividing the output of the second voltage sensing circuit 3924 by thecurrent sensing circuit 3914.

As shown in FIG. 47, the generator 3900 comprising at least one outputport can include a power transformer 3908 with a single output and withmultiple taps to provide power in the form of one or more energymodalities, such as ultrasonic, bipolar or monopolar RF, irreversibleand/or reversible electroporation, and/or microwave energy, amongothers, for example, to the end effector depending on the type oftreatment of tissue being performed. For example, the generator 3900 candeliver energy with higher voltage and lower current to drive anultrasonic transducer, with lower voltage and higher current to drive RFelectrodes for sealing tissue, or with a coagulation waveform for spotcoagulation using either monopolar or bipolar RF electrosurgicalelectrodes. The output waveform from the generator 3900 can be steered,switched, or filtered to provide the frequency to the end effector ofthe surgical instrument. The connection of an ultrasonic transducer tothe generator 3900 output would be preferably located between the outputlabeled ENERGY1 and RETURN as shown in FIG. 46. In one example, aconnection of RF bipolar electrodes to the generator 3900 output wouldbe preferably located between the output labeled ENERGY2 and RETURN. Inthe case of monopolar output, the preferred connections would be activeelectrode (e.g., pencil or other probe) to the ENERGY2 output and asuitable return pad connected to the RETURN output.

Additional details are disclosed in U.S. Patent Application PublicationNo. 2017/0086914, titled TECHNIQUES FOR OPERATING GENERATOR FORDIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICALINSTRUMENTS, which published on Mar. 30, 2017, which is hereinincorporated by reference in its entirety.

In one aspect, the present disclosure provides a modular energy systemconfigured to drive the combination ultrasonic/bipolar RF energysurgical device. FIG. 48 is a diagram of various modules and othercomponents that are combinable to customize modular energy systems, inaccordance with at least one aspect of the present disclosure. FIG. 49Ais a first illustrative modular energy system configuration including aheader module and a display screen that renders a graphical userinterface (GUI) for relaying information regarding modules connected tothe header module, in accordance with at least one aspect of the presentdisclosure. FIG. 49B is the modular energy system shown in FIG. 49Amounted to a cart, in accordance with at least one aspect of the presentdisclosure.

With reference now to FIGS. 47-49B, ORs everywhere in the world are atangled web of cords, devices, and people due to the amount of equipmentrequired to perform surgical procedures. Surgical capital equipmenttends to be a major contributor to this issue because most surgicalcapital equipment performs a single, specialized task. Due to theirspecialized nature and the surgeons' needs to utilize multiple differenttypes of devices during the course of a single surgical procedure, an ORmay be forced to be stocked with two or even more pieces of surgicalcapital equipment, such as energy generators. Each of these pieces ofsurgical capital equipment must be individually plugged into a powersource and may be connected to one or more other devices that are beingpassed between OR personnel, creating a tangle of cords that must benavigated. Another issue faced in modern ORs is that each of thesespecialized pieces of surgical capital equipment has its own userinterface and must be independently controlled from the other pieces ofequipment within the OR. This creates complexity in properly controllingmultiple different devices in connection with each other and forcesusers to be trained on and memorize different types of user interfaces(which may further change based upon the task or surgical procedurebeing performed, in addition to changing between each piece of capitalequipment). This cumbersome, complex process can necessitate the needfor even more individuals to be present within the OR and can createdanger if multiple devices are not properly controlled in tandem witheach other. Therefore, consolidating surgical capital equipmenttechnology into singular systems that are able to flexibly addresssurgeons' needs to reduce the footprint of surgical capital equipmentwithin ORs would simplify the user experience, reduce the amount ofclutter in ORs, and prevent difficulties and dangers associated withsimultaneously controlling multiple pieces of capital equipment.Further, making such systems expandable or customizable would allow fornew technology to be conveniently incorporated into existing surgicalsystems, obviating the need to replace entire surgical systems or for ORpersonnel to learn new user interfaces or equipment controls with eachnew technology.

A surgical hub can be configured to interchangeably receive a variety ofmodules, which can in turn interface with surgical devices (e.g., asurgical instrument or a smoke evacuator) or provide various otherfunctions (e.g., communications). In one aspect, a surgical hub can beembodied as a modular energy system 4000, which is illustrated inconnection with FIGS. 48-49B. The modular energy system 4000 can includea variety of different modules 4001 that are connectable together in astacked configuration. In one aspect, the modules 4001 can be bothphysically and communicably coupled together when stacked or otherwiseconnected together into a singular assembly. Further, the modules 4001can be interchangeably connectable together in different combinations orarrangements. In one aspect, each of the modules 4001 can include aconsistent or universal array of connectors disposed along their upperand lower surfaces, thereby allowing any module 4001 to be connected toanother module 4001 in any arrangement (except that, in some aspects, aparticular module type, such as the header module 4002, can beconfigured to serve as the uppermost module within the stack, forexample). In an alternative aspect, the modular energy system 4000 caninclude a housing that is configured to receive and retain the modules4001, as is shown in FIG. 46. The modular energy system 4000 can alsoinclude a variety of different components or accessories that are alsoconnectable to or otherwise associatable with the modules 4001. Inanother aspect, the modular energy system 4000 can be embodied as agenerator module 3140, 3900 (FIGS. 46-47) of a surgical hub 3106. In yetanother aspect, the modular energy system 4000 can be a distinct systemfrom a surgical hub 3106. In such aspects, the modular energy system4000 can be communicably couplable to a surgical hub 3106 fortransmitting and/or receiving data therebetween.

The modular energy system 4000 can be assembled from a variety ofdifferent modules 4001, some examples of which are illustrated in FIG.48. Each of the different types of modules 4001 can provide differentfunctionality, thereby allowing the modular energy system 4000 to beassembled into different configurations to customize the functions andcapabilities of the modular energy system 4000 by customizing themodules 4001 that are included in each modular energy system 4000. Themodules 4001 of the modular energy system 4000 can include, for example,a header module 4002 (which can include a display screen 4006), anenergy module 4004, a technology module 4040, and a visualization module4042. In the depicted aspect, the header module 4002 is configured toserve as the top or uppermost module within the modular energy systemstack and can thus lack connectors along its top surface. In anotheraspect, the header module 4002 can be configured to be positioned at thebottom or the lowermost module within the modular energy system stackand can thus lack connectors along its bottom surface. In yet anotheraspect, the header module 4002 can be configured to be positioned at anintermediate position within the modular energy system stack and canthus include connectors along both its bottom and top surfaces. Theheader module 4002 can be configured to control the system-wide settingsof each module 4001 and component connected thereto through physicalcontrols 4011 thereon and/or a graphical user interface (GUI) 4008rendered on the display screen 4006. Such settings could include theactivation of the modular energy system 4000, the volume of alerts, thefootswitch settings, the settings icons, the appearance or configurationof the user interface, the surgeon profile logged into the modularenergy system 4000, and/or the type of surgical procedure beingperformed. The header module 4002 can also be configured to providecommunications, processing, and/or power for the modules 4001 that areconnected to the header module 4002. The energy module 4004, which canalso be referred to as a generator module 3140, 3900 (FIGS. 46-47), canbe configured to generate one or multiple energy modalities for drivingelectrosurgical and/or ultrasonic surgical instruments connectedthereto, such as is described above in connection with the generator3900 illustrated in FIG. 47. The technology module 4040 can beconfigured to provide additional or expanded control algorithms (e.g.,electrosurgical or ultrasonic control algorithms for controlling theenergy output of the energy module 4004). The visualization module 4042can be configured to interface with visualization devices (i.e., scopes)and accordingly provide increased visualization capabilities.

The modular energy system 4000 can further include a variety ofaccessories 4029 that are connectable to the modules 4001 forcontrolling the functions thereof or that are otherwise configured towork on conjunction with the modular energy system 4000. The accessories4029 can include, for example, a single-pedal footswitch 4032, adual-pedal footswitch 4034, and a cart 4030 for supporting the modularenergy system 4000 thereon. The footswitches 4032, 4034 can beconfigured to control the activation or function of particular energymodalities output by the energy module 4004, for example.

By utilizing modular components, the depicted modular energy system 4000provides a surgical platform that grows with the availability oftechnology and is customizable to the needs of the facility and/orsurgeons. Further, the modular energy system 4000 supports combo devices(e.g., dual electrosurgical and ultrasonic energy generators) andsupports software-driven algorithms for customized tissue effects. Stillfurther, the surgical system architecture reduces the capital footprintby combining multiple technologies critical for surgery into a singlesystem.

The various modular components utilizable in connection with the modularenergy system 4000 can include monopolar energy generators, bipolarenergy generators, dual electrosurgical/ultrasonic energy generators,display screens, and various other modules and/or other components, someof which are also described above in connection with FIGS. 1-45.

Referring now to FIG. 49A, the header module 4002 can, in some aspects,include a display screen 4006 that renders a GUI 4008 for relayinginformation regarding the modules 4001 connected to the header module4002. In some aspects, the GUI 4008 of the display screen 4006 canprovide a consolidated point of control of all of the modules 4001making up the particular configuration of the modular energy system4000. In alternative aspects, the header module 4002 can lack thedisplay screen 4006 or the display screen 4006 can be detachablyconnected to the housing 4010 of the header module 4002. In suchaspects, the header module 4002 can be communicably couplable to anexternal system that is configured to display the information generatedby the modules 4001 of the modular energy system 4000. For example, inrobotic surgical applications, the modular energy system 4000 can becommunicably couplable to a robotic cart or robotic control console,which is configured to display the information generated by the modularenergy system 4000 to the operator of the robotic surgical system. Asanother example, the modular energy system 4000 can be communicablycouplable to a mobile display that can be carried or secured to asurgical staff member for viewing thereby. In yet another example, themodular energy system 4000 can be communicably couplable to a surgicalhub 4100 or another computer system that can include a display 4104. Inaspects utilizing a user interface that is separate from or otherwisedistinct from the modular energy system 4000, the user interface can bewirelessly connectable with the modular energy system 4000 as a whole orone or more modules 4001 thereof such that the user interface candisplay information from the connected modules 4001 thereon.

Referring still to FIG. 49A, the energy module 4004 can include a portassembly 4012 including a number of different ports configured todeliver different energy modalities to corresponding surgicalinstruments that are connectable thereto. In the particular aspectillustrated in FIGS. 48-49B, the port assembly 4012 includes a bipolarport 4014, a first monopolar port 4016 a, a second monopolar port 4018b, a neutral electrode port 4018 (to which a monopolar return pad isconnectable), and a combination energy port 4020. However, thisparticular combination of ports is simply provided for illustrativepurposes and alternative combinations of ports and/or energy modalitiesmay be possible for the port assembly 4012.

As noted above, the modular energy system 4000 can be assembled intodifferent configurations. Further, the different configurations of themodular energy system 4000 can also be utilizable for different surgicalprocedure types and/or different tasks. For example, FIGS. 49A and 49Billustrate a first illustrative configuration of the modular energysystem 4000 including a header module 4002 (including a display screen4006) and an energy module 4004 connected together. Such a configurationcan be suitable for laparoscopic and open surgical procedures, forexample.

FIGS. 50-54 illustrate an example surgical system 10 with ultrasonic andelectrosurgical features including any one of the end-effectors,surgical instruments, and generators described herein. FIG. 50 depicts asurgical system 10 including a generator 12 and a surgical instrument14. The surgical instrument 14 is operatively coupled with the generator12 via a power cable 16. The generator 12 is operable to power thesurgical instrument 14 to deliver ultrasonic energy for cutting tissue,and electrosurgical bipolar RF energy (i.e., therapeutic levels of RFenergy) for sealing tissue. In one aspect, the generator 12 isconfigured to power the surgical instrument 14 to deliver ultrasonicenergy and electrosurgical bipolar RF energy simultaneously orindependently.

The surgical instrument 14 of the present example comprises a handleassembly 18, a shaft assembly 20 extending distally from the handleassembly 18, and an end effector 22 arranged at a distal end of theshaft assembly 20. The handle assembly 18 comprises a body 24 includinga pistol grip 26 and energy control buttons 28, 30 configured to bemanipulated by a surgeon. A trigger 32 is coupled to a lower portion ofthe body 24 and is pivotable toward and away from the pistol grip 26 toselectively actuate the end effector 22, as described in greater detailbelow. In other suitable variations of the surgical instrument 14, thehandle assembly 18 may comprise a scissor grip configuration, forexample. An ultrasonic transducer 34 is housed internally within andsupported by the body 24. In other configurations, the ultrasonictransducer 34 may be provided externally of the body 24.

As shown in FIGS. 51 and 52, the end effector 22 includes an ultrasonicblade 36 and a clamp arm 38 configured to selectively pivot toward andaway from the ultrasonic blade 36, for clamping tissue therebetween. Theultrasonic blade 36 is acoustically coupled with the ultrasonictransducer 34, which is configured to drive (i.e., vibrate) theultrasonic blade 36 at ultrasonic frequencies for cutting and/or sealingtissue positioned in contact with the ultrasonic blade 36. The clamp arm38 is operatively coupled with the trigger 32 such that the clamp arm 38is configured to pivot toward the ultrasonic blade 36, to a closedposition, in response to pivoting of the trigger 32 toward the pistolgrip 26. Further, the clamp arm 38 is configured to pivot away from theultrasonic blade 36, to an open position (see e.g., FIGS. 50-52), inresponse to pivoting of the trigger 32 away from the pistol grip 26.Various suitable ways in which the clamp arm 38 may be coupled with thetrigger 32 will be apparent to those of ordinary skill in the art inview of the teachings provided herein. In some versions, one or moreresilient members may be incorporated to bias the clamp arm 38 and/orthe trigger 32 toward the open position.

A clamp pad 40 is secured to and extends distally along a clamping sideof the clamp arm 38, facing the ultrasonic blade 36. The clamp pad 40 isconfigured to engage and clamp tissue against a corresponding tissuetreatment portion of the ultrasonic blade 36 when the clamp arm 38 isactuated to its closed position. At least a clamping-side of the clamparm 38 provides a first electrode 42, referred to herein as clamp armelectrode 42. Additionally, at least a clamping-side of the ultrasonicblade 36 provides a second electrode 44, referred to herein as a bladeelectrode 44. The electrodes 42, 44 are configured to applyelectrosurgical bipolar RF energy, provided by the generator 12, totissue electrically coupled with the electrodes 42, 44. The clamp armelectrode 42 may serve as an active electrode while the blade electrode44 serves as a return electrode, or vice-versa. The surgical instrument14 may be configured to apply the electrosurgical bipolar RF energythrough the electrodes 42, 44 while vibrating the ultrasonic blade 36 atan ultrasonic frequency, before vibrating the ultrasonic blade 36 at anultrasonic frequency, and/or after vibrating the ultrasonic blade 36 atan ultrasonic frequency.

As shown in FIGS. 50-54, the shaft assembly 20 extends along alongitudinal axis and includes an outer tube 46, an inner tube 48received within the outer tube 46, and an ultrasonic waveguide 50supported within the inner tube 48. As seen best in FIGS. 51-54, theclamp arm 38 is coupled to distal ends of the inner and outer tubes 46,48. In particular, the clamp arm 38 includes a pair of proximallyextending clevis arms 52 that receive therebetween and pivotably coupleto a distal end 54 of the inner tube 48 with a pivot pin 56 receivedthrough bores formed in the clevis arms 52 and the distal end 54 of theinner tube 48. The first and second clevis fingers 58 depend downwardlyfrom the clevis arms 52 and pivotably couple to a distal end 60 of theouter tube 46. Specifically, each clevis finger 58 includes a protrusion62 that is rotatably received within a corresponding opening 64 formedin a sidewall of the distal end 60 of the outer tube 46.

In the present example, the inner tube 48 is longitudinally fixedrelative to the handle assembly 18, and the outer tube 46 is configuredto translate relative to the inner tube 48 and the handle assembly 18,along the longitudinal axis of the shaft assembly 20. As the outer tube46 translates distally, the clamp arm 38 pivots about the pivot pin 56toward its open position. As the outer tube 46 translates proximally,the clamp arm 38 pivots in an opposite direction toward its closedposition. A proximal end of the outer tube 46 is operatively coupledwith the trigger 32, for example via a linkage assembly, such thatactuation of the trigger 32 causes translation of the outer tube 46relative to the inner tube 48, thereby opening or closing the clamp arm38. In other suitable configurations not shown herein, the outer tube 46may be longitudinally fixed and the inner tube 48 may be configured totranslate for moving the clamp arm 38 between its open and closedpositions.

The shaft assembly 20 and the end effector 22 are configured to rotatetogether about the longitudinal axis, relative to the handle assembly18. A retaining pin 66, shown in FIG. 53, extends transversely throughthe proximal portions of the outer tube 46, the inner tube 48, and thewaveguide 50 to thereby couple these components rotationally relative toone another. In the present example, a rotation knob 68 is provided at aproximal end portion of the shaft assembly 20 to facilitate rotation ofthe shaft assembly 20, and the end effector 22, relative to the handleassembly 18. The rotation knob 68 is secured rotationally to the shaftassembly 20 with the retaining pin 66, which extends through a proximalcollar of the rotation knob 68. It will be appreciated that in othersuitable configurations, the rotation knob 68 may be omitted orsubstituted with alternative rotational actuation structures.

The ultrasonic waveguide 50 is acoustically coupled at its proximal endwith the ultrasonic transducer 34, for example by a threaded connection,and at its distal end with the ultrasonic blade 36, as shown in FIG. 54.The ultrasonic blade 36 is shown formed integrally with the waveguide 50such that the blade 36 extends distally, directly from the distal end ofthe waveguide 50. In this manner, the waveguide 50 acoustically couplesthe ultrasonic transducer 34 with the ultrasonic blade 36, and functionsto communicate ultrasonic mechanical vibrations from the transducer 34to the blade 36. Accordingly, the ultrasonic transducer 34, thewaveguide 50, and the ultrasonic blade 36 together define an acousticassembly. During use, the ultrasonic blade 36 may be positioned indirect contact with tissue, with or without assistive clamping forceprovided by the clamp arm 38, to impart ultrasonic vibrational energy tothe tissue and thereby cut and/or seal the tissue. For example, theblade 36 may cut through tissue clamped between the clamp arm 38 and afirst treatment side of the blade 36, or the blade 36 may cut throughtissue positioned in contact with an oppositely disposed secondtreatment side of the blade 36, for example during a “back-cutting”movement. In some variations, the waveguide 50 may amplify theultrasonic vibrations delivered to the blade 36. Further, the waveguide50 may include various features operable to control the gain of thevibrations, and/or features suitable to tune the waveguide 50 to aselected resonant frequency. Additional features of the ultrasonic blade36 and the waveguide 50 are described in greater detail below.

The waveguide 50 is supported within the inner tube 48 by a plurality ofnodal support elements 70 positioned along a length of the waveguide 50,as shown in FIGS. 53-54. Specifically, the nodal support elements 70 arepositioned longitudinally along the waveguide 50 at locationscorresponding to acoustic nodes defined by the resonant ultrasonicvibrations communicated through the waveguide 50. The nodal supportelements 70 may provide structural support to the waveguide 50, andacoustic isolation between the waveguide 50 and the inner and outertubes 46, 48 of the shaft assembly 20. In variations, the nodal supportelements 70 may comprise o-rings. The waveguide 50 is supported at itsdistal-most acoustic node by a nodal support element in the form of anovermold member 72, shown in FIG. 54. The waveguide 50 is securedlongitudinally and rotationally within the shaft assembly 20 by theretaining pin 66, which passes through a transverse through-bore 74formed at a proximally arranged acoustic node of the waveguide 50, suchas the proximal-most acoustic node, for example.

In the present example, a distal tip 76 of the ultrasonic blade 36 islocated at a position corresponding to an anti-node associated with theresonant ultrasonic vibrations communicated through the waveguide 50.Such a configuration enables the acoustic assembly of the instrument 14to be tuned to a preferred resonant frequency f_(o) when the ultrasonicblade 36 is not loaded by tissue. When the ultrasonic transducer 34 isenergized by the generator 12 to transmit mechanical vibrations throughthe waveguide 50 to the blade 36, the distal tip 76 of the blade 36 iscaused to oscillate longitudinally in the range of approximately 20 to120 microns peak-to-peak, for example, and in some instances in therange of approximately 20 to 50 microns, at a predetermined vibratoryfrequency f_(o) of approximately 50 kHz, for example. When theultrasonic blade 36 is positioned in contact with tissue, the ultrasonicoscillation of the blade 36 may simultaneously sever the tissue anddenature the proteins in adjacent tissue cells, thereby providing acoagulative effect with minimal thermal spread.

EXAMPLES

Examples of various aspects of end-effectors and surgical instruments ofthe present disclosure are provided below. An aspect of the end-effectoror surgical instrument may include any one or more than one, and anycombination of, the examples described below:

Example 1. An end-effector, comprising: a clamp arm; and an ultrasonicblade configured to acoustically couple to an ultrasonic transducer andto electrically couple to a pole of an electrical generator; wherein theclamp arm comprises: a clamp jaw having a proximal end and a distal end,the proximal end pivotally movable about a pivot point; a cantileverelectrode having a proximal end fixed to the proximal end of the clampjaw and a distal end that is free to deflect, the cantilever electrodedefining a surface configured to contact tissue and apply electricalenergy to the tissue in contact therewith, wherein the cantileverelectrode is configured to electrically couple to an opposite pole ofthe electrical generator, wherein the cantilever electrode is biased ina direction toward the clamp jaw; a retainer configured to oppose thebiasing force and to maintain the cantilever electrode in asubstantially flat configuration relative to the ultrasonic blade; and aclamp arm pad fixed to the clamp jaw and having at least a portiondisposed between the clamp jaw and the cantilever electrode and anotherportion extending beyond the surface of the cantilever electrode tocontact tissue.

Example 2. The end-effector of Example 1, wherein the retainer isconfigured as a tooth.

Example 3. The end-effector of any one of Examples 1-2, wherein theretainer is configured as a wall with a tapered profile.

Example 4. The end-effector of any one of Examples 1-3, wherein in afree-state, the cantilever electrode is pre-formed in a shape biasedtoward the clamp jaw.

Example 5. The end-effector of any one of Examples 1-4, wherein in afree-state, the cantilever electrode is bent in a shape biased towardthe clamp jaw.

Example 6. An end-effector, comprising: a clamp arm; and an ultrasonicblade configured to acoustically couple to an ultrasonic transducer andto electrically coupe to a pole of an electrical generator; wherein theclamp arm comprises: a clamp jaw having a proximal end and a distal end,the proximal end pivotally movable about a pivot point; a cantileverelectrode having a proximal end fixed to the proximal end of the clampjaw and a distal end that is free to deflect, the cantilever electrodedefining a surface configured to contact tissue and apply electricalenergy to the tissue in contact therewith, wherein the cantileverelectrode is configured to electrically couple to an opposite pole ofthe electrical generator, wherein the cantilever electrode is biased ina direction toward the clamp jaw; a clamp arm pad fixed to the clamp jawand having at least a portion disposed between the clamp jaw and thecantilever electrode and another portion extending beyond the surface ofthe cantilever electrode to contact tissue; and a skirt disposed arounda distal end of the clamp jaw to surround the distal end of the clamparm pad.

Example 7. The end-effector of Example 6, wherein the skirt isconfigured to contain the clamp arm pad as the clamp arm pad heats anddeforms to prevent the clamp arm pad from expanding laterally.

Example 8. The end-effector of any one of Examples 6-7, wherein thecantilever electrode is biased.

Example 9. The end-effector of Example 8, wherein the cantileverelectrode has a higher bias at the distal end compared to the proximalend.

Example 10. A surgical instrument, comprising: a housing; an ultrasonictransducer; and an end-effector comprising: a clamp arm; and anultrasonic blade acoustically coupled to the ultrasonic transducer andelectrically coupled to a pole of an electrical generator; wherein theclamp arm comprises: a clamp jaw having a proximal end and a distal end,the proximal end pivotally movable about a pivot point; a cantileverelectrode having a proximal end fixed to the proximal end of the clampjaw and a distal end that is free to deflect, the cantilever electrodedefining a surface configured to contact tissue and apply electricalenergy to the tissue in contact therewith, wherein the cantileverelectrode is configured to electrically couple to an opposite pole ofthe electrical generator, wherein the cantilever electrode is biased ina direction toward the clamp jaw; a retainer configured to oppose thebiasing force and to maintain the cantilever electrode in asubstantially flat configuration relative to the ultrasonic blade; and aclamp arm pad fixed to the clamp jaw and having at least a portiondisposed between the clamp jaw and the cantilever electrode and anotherportion extending beyond the surface of the cantilever electrode tocontact tissue.

Example 11. The surgical instrument of Example 10, wherein the retaineris configured as a tooth.

Example 12. The surgical instrument of any one of Examples 10-11,wherein the retainer is configured as a wall with a tapered profile.

Example 13. The surgical instrument of any one of Examples 10-12,wherein in a free-state, the cantilever electrode is pre-formed in ashape biased toward the clamp jaw.

Example 14. The surgical instrument of any one of Examples 10-13,wherein in a free-state, the cantilever electrode is bent in a shapebiased toward the clamp jaw.

Example 15. The surgical instrument of any one of Examples 10-14,wherein the end-effector further comprises a skirt disposed around adistal end of the clamp jaw to surround the distal end of the clamp armpad.

Example 16. The surgical instrument of Example 15, wherein the skirt isconfigured to contain the clamp arm pad as the clamp arm pad heats anddeforms to prevent the clamp arm pad from expanding laterally.

Example 17. The surgical instrument of any one of Example 10-16, wherein the cantilever electrode is biased.

Example 18. The surgical instrument of any one of Examples 10-17,wherein the cantilever electrode has a higher bias at the distal endcompared to the proximal end.

Example 19. An end-effector, comprising: a clamp arm; and an ultrasonicblade configured to acoustically couple to an ultrasonic transducer andto electrically couple to a pole of an electrical generator; wherein theclamp arm comprises: a clamp jaw having a proximal end and a distal end,the proximal end pivotally movable about a pivot point; a cantileverelectrode having a proximal end fixed to the proximal end of the clampjaw and a distal end that is free to deflect, the cantilever electrodedefining a surface configured to contact tissue and apply electricalenergy to the tissue in contact therewith, wherein the cantileverelectrode is configured to couple to an opposite pole of the electricalgenerator; a clamp arm pad fixed to the clamp jaw and having at least aportion disposed between the clamp jaw and the cantilever electrode andanother portion extending beyond the surface of the cantilever electrodeto contact tissue, wherein the clamp arm pad comprises multiple supportelements arranged in multiple rows to support the cantilever electrode;and a skirt disposed around a distal end of the clamp jaw to surroundthe distal end of the clamp arm pad.

Example 20. The end-effector of Example 19, wherein as the clamp arm padheats up, a row of support elements melt and wear away causing thecantilever electrode to drop in height.

Example 21. The end-effector of Example 20, wherein as the clamp arm padcontinues to heat up, additional rows row support elements melt and wearaway causing the height of the cantilever electrode to further drop inheight.

Example 22. A surgical instrument, comprising: a housing; an ultrasonictransducer; and an end-effector comprising: a clamp arm; an ultrasonicblade acoustically coupled to the ultrasonic transducer and electricallycoupled to a pole of an electrical generator; wherein the clamp armcomprises: a clamp jaw having a proximal end and a distal end, theproximal end pivotally movable about a pivot point; a cantileverelectrode having a proximal end fixed to the proximal end of the clampjaw and a distal end that is free to deflect, the cantilever electrodedefining a surface configured to contact tissue and apply electricalenergy to the tissue in contact therewith, wherein the cantileverelectrode is acoustically coupled to an opposite pole of the electricalgenerator; a clamp arm pad fixed to the clamp jaw and having at least aportion disposed between the clamp jaw and the cantilever electrode andanother portion extending beyond the surface of the cantilever electrodeto contact tissue, wherein the clamp arm pad comprises multiple supportelements arranged in multiple rows to support the cantilever electrode;and a skirt disposed around a distal end of the clamp jaw to surroundthe distal end of the clamp arm pad.

Example 23. The surgical instrument of Example 22, wherein as the clamparm pad heats up, a row of support elements melt and wear away causingthe cantilever electrode to drop in height.

Example 24. The surgical instrument of Example 23, wherein as the clamparm pad continues to heat up, additional rows row support elements meltand wear away causing the height of the cantilever electrode to furtherdrop in height.

While several forms have been illustrated and described, it is not theintention of Applicant to restrict or limit the scope of the appendedclaims to such detail. Numerous modifications, variations, changes,substitutions, combinations, and equivalents to those forms may beimplemented and will occur to those skilled in the art without departingfrom the scope of the present disclosure. Moreover, the structure ofeach element associated with the described forms can be alternativelydescribed as a means for providing the function performed by theelement. Also, where materials are disclosed for certain components,other materials may be used. It is therefore to be understood that theforegoing description and the appended claims are intended to cover allsuch modifications, combinations, and variations as falling within thescope of the disclosed forms. The appended claims are intended to coverall such modifications, variations, changes, substitutions,modifications, and equivalents.

The foregoing detailed description has set forth various forms of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, and/or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof.Those skilled in the art will recognize that some aspects of the formsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, those skilled inthe art will appreciate that the mechanisms of the subject matterdescribed herein are capable of being distributed as one or more programproducts in a variety of forms, and that an illustrative form of thesubject matter described herein applies regardless of the particulartype of signal bearing medium used to actually carry out thedistribution.

Instructions used to program logic to perform various disclosed aspectscan be stored within a memory in the system, such as dynamic randomaccess memory (DRAM), cache, flash memory, or other storage.Furthermore, the instructions can be distributed via a network or by wayof other computer readable media. Thus a machine-readable medium mayinclude any mechanism for storing or transmitting information in a formreadable by a machine (e.g., a computer), but is not limited to, floppydiskettes, optical disks, compact disc, read-only memory (CD-ROMs), andmagneto-optical disks, read-only memory (ROMs), random access memory(RAM), erasable programmable read-only memory (EPROM), electricallyerasable programmable read-only memory (EEPROM), magnetic or opticalcards, flash memory, or a tangible, machine-readable storage used in thetransmission of information over the Internet via electrical, optical,acoustical or other forms of propagated signals (e.g., carrier waves,infrared signals, digital signals, etc.). Accordingly, thenon-transitory computer-readable medium includes any type of tangiblemachine-readable medium suitable for storing or transmitting electronicinstructions or information in a form readable by a machine (e.g., acomputer).

As used in any aspect herein, the term “control circuit” may refer to,for example, hardwired circuitry, programmable circuitry (e.g., acomputer processor including one or more individual instructionprocessing cores, processing unit, processor, microcontroller,microcontroller unit, controller, digital signal processor (DSP),programmable logic device (PLD), programmable logic array (PLA), orfield programmable gate array (FPGA)), state machine circuitry, firmwarethat stores instructions executed by programmable circuitry, and anycombination thereof. The control circuit may, collectively orindividually, be embodied as circuitry that forms part of a largersystem, for example, an integrated circuit (IC), an application-specificintegrated circuit (ASIC), a system on-chip (SoC), desktop computers,laptop computers, tablet computers, servers, smart phones, etc.Accordingly, as used herein “control circuit” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of random access memory), and/or electricalcircuitry forming a communications device (e.g., a modem, communicationsswitch, or optical-electrical equipment). Those having skill in the artwill recognize that the subject matter described herein may beimplemented in an analog or digital fashion or some combination thereof.

As used in any aspect herein, the term “logic” may refer to an app,software, firmware and/or circuitry configured to perform any of theaforementioned operations. Software may be embodied as a softwarepackage, code, instructions, instruction sets and/or data recorded onnon-transitory computer readable storage medium. Firmware may beembodied as code, instructions or instruction sets and/or data that arehard-coded (e.g., nonvolatile) in memory devices.

As used in any aspect herein, the terms “component,” “system,” “module”and the like can refer to a computer-related entity, either hardware, acombination of hardware and software, software, or software inexecution.

As used in any aspect herein, an “algorithm” refers to a self-consistentsequence of steps leading to a desired result, where a “step” refers toa manipulation of physical quantities and/or logic states which may,though need not necessarily, take the form of electrical or magneticsignals capable of being stored, transferred, combined, compared, andotherwise manipulated. It is common usage to refer to these signals asbits, values, elements, symbols, characters, terms, numbers, or thelike. These and similar terms may be associated with the appropriatephysical quantities and are merely convenient labels applied to thesequantities and/or states.

A network may include a packet switched network. The communicationdevices may be capable of communicating with each other using a selectedpacket switched network communications protocol. One examplecommunications protocol may include an Ethernet communications protocolwhich may be capable permitting communication using a TransmissionControl Protocol/Internet Protocol (TCP/IP). The Ethernet protocol maycomply or be compatible with the Ethernet standard published by theInstitute of Electrical and Electronics Engineers (IEEE) titled “IEEE802.3 Standard”, published in December, 2008 and/or later versions ofthis standard. Alternatively or additionally, the communication devicesmay be capable of communicating with each other using an X.25communications protocol. The X.25 communications protocol may comply orbe compatible with a standard promulgated by the InternationalTelecommunication Union-Telecommunication Standardization Sector(ITU-T). Alternatively or additionally, the communication devices may becapable of communicating with each other using a frame relaycommunications protocol. The frame relay communications protocol maycomply or be compatible with a standard promulgated by ConsultativeCommittee for International Telegraph and Telephone (CCITT) and/or theAmerican National Standards Institute (ANSI). Alternatively oradditionally, the transceivers may be capable of communicating with eachother using an Asynchronous Transfer Mode (ATM) communications protocol.The ATM communications protocol may comply or be compatible with an ATMstandard published by the ATM Forum titled “ATM-MPLS NetworkInterworking 2.0” published August 2001, and/or later versions of thisstandard. Of course, different and/or after-developedconnection-oriented network communication protocols are equallycontemplated herein.

Unless specifically stated otherwise as apparent from the foregoingdisclosure, it is appreciated that, throughout the foregoing disclosure,discussions using terms such as “processing,” “computing,”“calculating,” “determining,” “displaying,” or the like, refer to theaction and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

One or more components may be referred to herein as “configured to,”“configurable to,” “operable/operative to,” “adapted/adaptable,” “ableto,” “conformable/conformed to,” etc. Those skilled in the art willrecognize that “configured to” can generally encompass active-statecomponents and/or inactive-state components and/or standby-statecomponents, unless context requires otherwise.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” refers to the portion closest to the clinician andthe term “distal” refers to the portion located away from the clinician.It will be further appreciated that, for convenience and clarity,spatial terms such as “vertical”, “horizontal”, “up”, and “down” may beused herein with respect to the drawings. However, surgical instrumentsare used in many orientations and positions, and these terms are notintended to be limiting and/or absolute.

Those skilled in the art will recognize that, in general, terms usedherein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flow diagrams arepresented in a sequence(s), it should be understood that the variousoperations may be performed in other orders than those which areillustrated, or may be performed concurrently. Examples of suchalternate orderings may include overlapping, interleaved, interrupted,reordered, incremental, preparatory, supplemental, simultaneous,reverse, or other variant orderings, unless context dictates otherwise.Furthermore, terms like “responsive to,” “related to,” or otherpast-tense adjectives are generally not intended to exclude suchvariants, unless context dictates otherwise.

It is worthy to note that any reference to “one aspect,” “an aspect,”“an exemplification,” “one exemplification,” and the like means that aparticular feature, structure, or characteristic described in connectionwith the aspect is included in at least one aspect. Thus, appearances ofthe phrases “in one aspect,” “in an aspect,” “in an exemplification,”and “in one exemplification” in various places throughout thespecification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or otherdisclosure material referred to in this specification and/or listed inany Application Data Sheet is incorporated by reference herein, to theextent that the incorporated materials is not inconsistent herewith. Assuch, and to the extent necessary, the disclosure as explicitly setforth herein supersedes any conflicting material incorporated herein byreference. Any material, or portion thereof, that is said to beincorporated by reference herein, but which conflicts with existingdefinitions, statements, or other disclosure material set forth hereinwill only be incorporated to the extent that no conflict arises betweenthat incorporated material and the existing disclosure material.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more forms has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more forms were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousforms and with various modifications as are suited to the particular usecontemplated. It is intended that the claims submitted herewith definethe overall scope.

1. An end-effector, comprising: a clamp arm; and an ultrasonic bladeconfigured to acoustically couple to an ultrasonic transducer and toelectrically couple to a pole of an electrical generator; wherein theclamp arm comprises: a clamp jaw having a proximal end and a distal end,the proximal end pivotally movable about a pivot point; a cantileverelectrode having a proximal end fixed to the proximal end of the clampjaw and a distal end that is free to deflect, the cantilever electrodedefining a surface configured to contact tissue and apply electricalenergy to the tissue in contact therewith, wherein the cantileverelectrode is configured to electrically couple to an opposite pole ofthe electrical generator, wherein the cantilever electrode is biased ina direction toward the clamp jaw; a retainer configured to oppose thebiasing force and to maintain the cantilever electrode in asubstantially flat configuration relative to the ultrasonic blade; and aclamp arm pad fixed to the clamp jaw and having at least a portiondisposed between the clamp jaw and the cantilever electrode and anotherportion extending beyond the surface of the cantilever electrode tocontact tissue.
 2. The end-effector of claim 1, wherein the retainer isconfigured as a tooth.
 3. The end-effector of claim 1, wherein theretainer is configured as a wall with a tapered profile.
 4. Theend-effector of claim 1, wherein in a free-state, the cantileverelectrode is pre-formed in a shape biased toward the clamp jaw.
 5. Theend-effector of claim 1, wherein in a free-state, the cantileverelectrode is bent in a shape biased toward the clamp jaw.
 6. Anend-effector, comprising: a clamp arm; and an ultrasonic bladeconfigured to acoustically couple to an ultrasonic transducer and toelectrically couple to a pole of an electrical generator; wherein theclamp arm comprises: a clamp jaw having a proximal end and a distal end,the proximal end pivotally movable about a pivot point; a cantileverelectrode having a proximal end fixed to the proximal end of the clampjaw and a distal end that is free to deflect, the cantilever electrodedefining a surface configured to contact tissue and apply electricalenergy to the tissue in contact therewith, wherein the cantileverelectrode is configured to electrically couple to an opposite pole ofthe electrical generator, wherein the cantilever electrode is biased ina direction toward the clamp jaw; a clamp arm pad fixed to the clamp jawand having at least a portion disposed between the clamp jaw and thecantilever electrode and another portion extending beyond the surface ofthe cantilever electrode to contact tissue; and a skirt disposed arounda distal end of the clamp jaw to surround the distal end of the clamparm pad.
 7. The end-effector of claim 6, wherein the skirt is configuredto contain the clamp arm pad as the clamp arm pad heats and deforms toprevent the clamp arm pad from expanding laterally.
 8. The end-effectorof claim 6, wherein the cantilever electrode is biased.
 9. Theend-effector of claim 8, wherein the cantilever electrode has a higherbias at the distal end compared to the proximal end.
 10. A surgicalinstrument, comprising: a housing; an ultrasonic transducer; and anend-effector comprising: a clamp arm; and an ultrasonic blade configuredto acoustically couple to the ultrasonic transducer and to electricallycouple to a pole of an electrical generator; wherein the clamp armcomprises: a clamp jaw having a proximal end and a distal end, theproximal end pivotally movable about a pivot point; a cantileverelectrode having a proximal end fixed to the proximal end of the clampjaw and a distal end that is free to deflect, the cantilever electrodedefining a surface configured to contact tissue and apply electricalenergy to the tissue in contact therewith, wherein the cantileverelectrode is configured to couple to an opposite pole of the electricalgenerator, wherein the cantilever electrode is biased in a directiontoward the clamp jaw; a retainer configured to oppose the biasing forceand to maintain the cantilever electrode in a substantially flatconfiguration relative to the ultrasonic blade; and a clamp arm padfixed to the clamp jaw and having at least a portion disposed betweenthe clamp jaw and the cantilever electrode and another portion extendingbeyond the surface of the cantilever electrode to contact tissue. 11.The surgical instrument of claim 10, wherein the retainer is configuredas a tooth.
 12. The surgical instrument of claim 10, wherein theretainer is configured as a wall with a tapered profile.
 13. Thesurgical instrument of claim 10, wherein in a free-state, the cantileverelectrode is pre-formed in a shape biased toward the clamp jaw.
 14. Thesurgical instrument of claim 10, wherein in a free-state, the cantileverelectrode is bent in a shape biased toward the clamp jaw.
 15. Thesurgical instrument of claim 10, wherein the end-effector furthercomprises a skirt disposed around a distal end of the clamp jaw tosurround the distal end of the clamp arm pad.
 16. The surgicalinstrument of claim 15, wherein the skirt is configured to contain theclamp arm pad as the clamp arm pad heats and deforms to prevent theclamp arm pad from expanding laterally.
 17. The surgical instrument ofclaim 10, where in the cantilever electrode is biased.
 18. The surgicalinstrument of claim 17, wherein the cantilever electrode has a higherbias at the distal end compared to the proximal end.
 19. Anend-effector, comprising: a clamp arm; and an ultrasonic bladeconfigured to acoustically couple to an ultrasonic transducer and toelectrically couple to a pole of an electrical generator; wherein theclamp arm comprises: a clamp jaw having a proximal end and a distal end,the proximal end pivotally movable about a pivot point; a cantileverelectrode having a proximal end fixed to the proximal end of the clampjaw and a distal end that is free to deflect, the cantilever electrodedefining a surface configured to contact tissue and apply electricalenergy to the tissue in contact therewith, wherein the cantileverelectrode is configured to electrically couple to an opposite pole ofthe electrical generator; a clamp arm pad fixed to the clamp jaw andhaving at least a portion disposed between the clamp jaw and thecantilever electrode and another portion extending beyond the surface ofthe cantilever electrode to contact tissue, wherein the clamp arm padcomprises multiple support elements arranged in multiple rows to supportthe cantilever electrode; and a skirt disposed around a distal end ofthe clamp jaw to surround the distal end of the clamp arm pad.
 20. Theend-effector of claim 19, wherein as the clamp arm pad heats up, a rowof support elements melt and wear away causing the cantilever electrodeto drop in height.
 21. The end-effector of claim 20, wherein as theclamp arm pad continues to heat up, additional rows row support elementsmelt and wear away causing the height of the cantilever electrode tofurther drop in height.
 22. A surgical instrument, comprising: ahousing; an ultrasonic transducer; and an end-effector comprising: aclamp arm; and an ultrasonic blade coupled to the ultrasonic transducerand electrically coupled to a pole of an electrical generator; whereinthe clamp arm comprises: a clamp jaw having a proximal end and a distalend, the proximal end pivotally movable about a pivot point; acantilever electrode having a proximal end fixed to the proximal end ofthe clamp jaw and a distal end that is free to deflect, the cantileverelectrode defining a surface configured to contact tissue and applyelectrical energy to the tissue in contact therewith, wherein thecantilever electrode is electrically coupled to an opposite pole of theelectrical generator; a clamp arm pad fixed to the clamp jaw and havingat least a portion disposed between the clamp jaw and the cantileverelectrode and another portion extending beyond the surface of thecantilever electrode to contact tissue, wherein the clamp arm padcomprises multiple support elements arranged in multiple rows to supportthe cantilever electrode; and a skirt disposed around a distal end ofthe clamp jaw to surround the distal end of the clamp arm pad.
 23. Thesurgical instrument of claim 22, wherein as the clamp arm pad heats up,a row of support elements melt and wear away causing the cantileverelectrode to drop in height.
 24. The surgical instrument of claim 23,wherein as the clamp arm pad continues to heat up, additional rows rowsupport elements melt and wear away causing the height of the cantileverelectrode to further drop in height.